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Meta-Analysis
. 2018 Jan 23;1(1):CD012529.
doi: 10.1002/14651858.CD012529.pub2.

Interventions to reduce acute and late adverse gastrointestinal effects of pelvic radiotherapy for primary pelvic cancers

Theresa A Lawrie  1 , John T Green, Mark Beresford, Linda Wedlake, Sorrel Burden, Susan E Davidson, Simon Lal, Caroline C Henson, H Jervoise N Andreyev
Affiliations
Meta-Analysis

Interventions to reduce acute and late adverse gastrointestinal effects of pelvic radiotherapy for primary pelvic cancers

Theresa A Lawrie et al. Cochrane Database Syst Rev. .

Abstract

Background: An increasing number of people survive cancer but a significant proportion have gastrointestinal side effects as a result of radiotherapy (RT), which impairs their quality of life (QoL).

Objectives: To determine which prophylactic interventions reduce the incidence, severity or both of adverse gastrointestinal effects among adults receiving radiotherapy to treat primary pelvic cancers.

Search methods: We conducted searches of CENTRAL, MEDLINE, and Embase in September 2016 and updated them on 2 November 2017. We also searched clinical trial registries.

Selection criteria: We included randomised controlled trials (RCTs) of interventions to prevent adverse gastrointestinal effects of pelvic radiotherapy among adults receiving radiotherapy to treat primary pelvic cancers, including radiotherapy techniques, other aspects of radiotherapy delivery, pharmacological interventions and non-pharmacological interventions. Studies needed a sample size of 20 or more participants and needed to evaluate gastrointestinal toxicity outcomes. We excluded studies that evaluated dosimetric parameters only. We also excluded trials of interventions to treat acute gastrointestinal symptoms, trials of altered fractionation and dose escalation schedules, and trials of pre- versus postoperative radiotherapy regimens, to restrict the vast scope of the review.

Data collection and analysis: We used standard Cochrane methodology. We used the random-effects statistical model for all meta-analyses, and the GRADE system to rate the certainty of the evidence.

Main results: We included 92 RCTs involving more than 10,000 men and women undergoing pelvic radiotherapy. Trials involved 44 different interventions, including radiotherapy techniques (11 trials, 4 interventions/comparisons), other aspects of radiotherapy delivery (14 trials, 10 interventions), pharmacological interventions (38 trials, 16 interventions), and non-pharmacological interventions (29 trials, 13 interventions). Most studies (79/92) had design limitations. Thirteen studies had a low risk of bias, 50 studies had an unclear risk of bias and 29 studies had a high risk of bias. Main findings include the following:Radiotherapy techniques: Intensity-modulated radiotherapy (IMRT) versus 3D conformal RT (3DCRT) may reduce acute (risk ratio (RR) 0.48, 95% confidence interval (CI) 0.26 to 0.88; participants = 444; studies = 4; I2 = 77%; low-certainty evidence) and late gastrointestinal (GI) toxicity grade 2+ (RR 0.37, 95% CI 0.21 to 0.65; participants = 332; studies = 2; I2 = 0%; low-certainty evidence). Conformal RT (3DCRT or IMRT) versus conventional RT reduces acute GI toxicity grade 2+ (RR 0.57, 95% CI 0.40 to 0.82; participants = 307; studies = 2; I2 = 0%; high-certainty evidence) and probably leads to less late GI toxicity grade 2+ (RR 0.49, 95% CI 0.22 to 1.09; participants = 517; studies = 3; I2 = 44%; moderate-certainty evidence). When brachytherapy (BT) is used instead of external beam radiotherapy (EBRT) in early endometrial cancer, evidence indicates that it reduces acute GI toxicity (grade 2+) (RR 0.02, 95% CI 0.00 to 0.18; participants = 423; studies = 1; high-certainty evidence).Other aspects of radiotherapy delivery: There is probably little or no difference in acute GI toxicity grade 2+ with reduced radiation dose volume (RR 1.21, 95% CI 0.81 to 1.81; participants = 211; studies = 1; moderate-certainty evidence) and maybe no difference in late GI toxicity grade 2+ (RR 1.02, 95% CI 0.15 to 6.97; participants = 107; studies = 1; low-certainty evidence). Evening delivery of RT may reduce acute GI toxicity (diarrhoea) grade 2+ during RT compared with morning delivery of RT (RR 0.51, 95% CI 0.34 to 0.76; participants = 294; studies = 2; I2 = 0%; low-certainty evidence). There may be no difference in acute (RR 2.22, 95% CI 0.62 to 7.93, participants = 110; studies = 1) and late GI toxicity grade 2+ (RR 0.44, 95% CI 0.12 to 1.65; participants = 81; studies = 1) between a bladder volume preparation of 1080 mls and that of 540 mls (low-certainty evidence). Low-certainty evidence on balloon and hydrogel spacers suggests that these interventions for prostate cancer RT may make little or no difference to GI outcomes.Pharmacological interventions: Evidence for any beneficial effects of aminosalicylates, sucralfate, amifostine, corticosteroid enemas, bile acid sequestrants, famotidine and selenium is of a low or very low certainty. However, evidence on certain aminosalicylates (mesalazine, olsalazine), misoprostol suppositories, oral magnesium oxide and octreotide injections suggests that these agents may worsen GI symptoms, such as diarrhoea or rectal bleeding.Non-pharmacological interventions: Low-certainty evidence suggests that protein supplements (RR 0.23, 95% CI 0.07 to 0.74; participants = 74; studies = 1), dietary counselling (RR 0.04, 95% CI 0.00 to 0.60; participants = 74; studies = 1) and probiotics (RR 0.43, 95% CI 0.22 to 0.82; participants = 923; studies = 5; I2 = 91%) may reduce acute RT-related diarrhoea (grade 2+). Dietary counselling may also reduce diarrhoeal symptoms in the long term (at five years, RR 0.05, 95% CI 0.00 to 0.78; participants = 61; studies = 1). Low-certainty evidence from one study (108 participants) suggests that a high-fibre diet may have a beneficial effect on GI symptoms (mean difference (MD) 6.10, 95% CI 1.71 to 10.49) and quality of life (MD 20.50, 95% CI 9.97 to 31.03) at one year. High-certainty evidence indicates that glutamine supplements do not prevent RT-induced diarrhoea. Evidence on various other non-pharmacological interventions, such as green tea tablets, is lacking.Quality of life was rarely and inconsistently reported across included studies, and the available data were seldom adequate for meta-analysis.

Authors' conclusions: Conformal radiotherapy techniques are an improvement on older radiotherapy techniques. IMRT may be better than 3DCRT in terms of GI toxicity, but the evidence to support this is uncertain. There is no high-quality evidence to support the use of any other prophylactic intervention evaluated. However, evidence on some potential interventions shows that they probably have no role to play in reducing RT-related GI toxicity. More RCTs are needed for interventions with limited evidence suggesting potential benefits.

PubMed Disclaimer

Conflict of interest statement

Theresa Lawrie: none declared Mark Beresford: none declared John Green: none declared Linda Wedlake: none declared Sorrel Burden: none declared Simon Lal: none declared Susan Davidson: none declared Caroline Henson: none declared Jervoise Andreyev: none declared

Figures

1
1
192Study flow diagram
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Conformal RT vs conventional RT, Outcome 1: Acute GI toxicity: grade 2+
1.2
1.2. Analysis
Comparison 1: Conformal RT vs conventional RT, Outcome 2: Late GI toxicity: grade 2+
1.3
1.3. Analysis
Comparison 1: Conformal RT vs conventional RT, Outcome 3: Acute GI toxicity: grade 1+
1.4
1.4. Analysis
Comparison 1: Conformal RT vs conventional RT, Outcome 4: Late GI toxicity: grade 1+
1.5
1.5. Analysis
Comparison 1: Conformal RT vs conventional RT, Outcome 5: Vomiting: grade 2+
1.6
1.6. Analysis
Comparison 1: Conformal RT vs conventional RT, Outcome 6: Medication for GI symptom control
2.1
2.1. Analysis
Comparison 2: IMRT vs 3DCRT, Outcome 1: GI symptom score (6 months)
2.2
2.2. Analysis
Comparison 2: IMRT vs 3DCRT, Outcome 2: GI symptom score (2 years)
2.3
2.3. Analysis
Comparison 2: IMRT vs 3DCRT, Outcome 3: Acute GI toxicity: grade 2+
2.4
2.4. Analysis
Comparison 2: IMRT vs 3DCRT, Outcome 4: Late GI toxicity: grade 2+
2.5
2.5. Analysis
Comparison 2: IMRT vs 3DCRT, Outcome 5: Acute GI toxicity: grade 1+
2.6
2.6. Analysis
Comparison 2: IMRT vs 3DCRT, Outcome 6: Late GI toxicity: grade 1+
2.7
2.7. Analysis
Comparison 2: IMRT vs 3DCRT, Outcome 7: Diarrhoea: grade 2+
2.8
2.8. Analysis
Comparison 2: IMRT vs 3DCRT, Outcome 8: Vomiting: grade 2+
3.1
3.1. Analysis
Comparison 3: Brachytherapy vs EBRT, Outcome 1: Acute GI toxicity: grade 2+
3.2
3.2. Analysis
Comparison 3: Brachytherapy vs EBRT, Outcome 2: Late GI toxicity: grade 2+
3.3
3.3. Analysis
Comparison 3: Brachytherapy vs EBRT, Outcome 3: Acute GI toxicity: grade 1
3.4
3.4. Analysis
Comparison 3: Brachytherapy vs EBRT, Outcome 4: Late GI toxicity: grade 1
3.5
3.5. Analysis
Comparison 3: Brachytherapy vs EBRT, Outcome 5: Treatment discontinuation
4.1
4.1. Analysis
Comparison 4: Reduced dose volume vs standard dose volume, Outcome 1: Acute GI toxicity: grade 2+
4.2
4.2. Analysis
Comparison 4: Reduced dose volume vs standard dose volume, Outcome 2: Acute GI toxicity: grade 1+
4.3
4.3. Analysis
Comparison 4: Reduced dose volume vs standard dose volume, Outcome 3: Late GI toxicity: grade 2+ (1 year post‐RT)
4.4
4.4. Analysis
Comparison 4: Reduced dose volume vs standard dose volume, Outcome 4: Late GI toxicity: grade 2+ (2 years post‐RT)
4.5
4.5. Analysis
Comparison 4: Reduced dose volume vs standard dose volume, Outcome 5: Late GI toxicity: grade 1+
5.1
5.1. Analysis
Comparison 5: Higher BV prep vs lower BV prep, Outcome 1: Acute GI toxicity: grade 2+
5.2
5.2. Analysis
Comparison 5: Higher BV prep vs lower BV prep, Outcome 2: Acute GI toxicity: grade 1+
5.3
5.3. Analysis
Comparison 5: Higher BV prep vs lower BV prep, Outcome 3: Late GI toxicity: grade 2+
5.4
5.4. Analysis
Comparison 5: Higher BV prep vs lower BV prep, Outcome 4: Late GI toxicity: grade 1+
6.1
6.1. Analysis
Comparison 6: Evening RT vs morning RT, Outcome 1: Acute GI toxicity (diarrhoea): grade 2+ (during RT)
6.2
6.2. Analysis
Comparison 6: Evening RT vs morning RT, Outcome 2: Acute GI toxicity (diarrhoea): grade 1+ (during RT)
6.3
6.3. Analysis
Comparison 6: Evening RT vs morning RT, Outcome 3: Vomiting grade 2+ (during RT)
7.1
7.1. Analysis
Comparison 7: Perineal hydrogel spacer vs no intervention, Outcome 1: Acute GI toxicity: grade 2+
7.2
7.2. Analysis
Comparison 7: Perineal hydrogel spacer vs no intervention, Outcome 2: Acute GI toxicity: grade 1+
7.3
7.3. Analysis
Comparison 7: Perineal hydrogel spacer vs no intervention, Outcome 3: Late GI toxicity: grade 2+
7.4
7.4. Analysis
Comparison 7: Perineal hydrogel spacer vs no intervention, Outcome 4: Late GI toxicity: grade 1+
7.5
7.5. Analysis
Comparison 7: Perineal hydrogel spacer vs no intervention, Outcome 5: Rectal bleeding (late)
7.6
7.6. Analysis
Comparison 7: Perineal hydrogel spacer vs no intervention, Outcome 6: Rectal pain (acute)
8.1
8.1. Analysis
Comparison 8: Endorectal balloon vs no intervention, Outcome 1: Acute GI toxicity: grade 2+
8.2
8.2. Analysis
Comparison 8: Endorectal balloon vs no intervention, Outcome 2: Acute GI toxicity: grade 1+
8.3
8.3. Analysis
Comparison 8: Endorectal balloon vs no intervention, Outcome 3: Late GI toxicity: grade 2+
8.4
8.4. Analysis
Comparison 8: Endorectal balloon vs no intervention, Outcome 4: Late GI toxicity: grade 1+
8.5
8.5. Analysis
Comparison 8: Endorectal balloon vs no intervention, Outcome 5: Diarrhoea (late)
8.6
8.6. Analysis
Comparison 8: Endorectal balloon vs no intervention, Outcome 6: Rectal bleeding (acute)
8.7
8.7. Analysis
Comparison 8: Endorectal balloon vs no intervention, Outcome 7: Rectal bleeding (late)
9.1
9.1. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 1: Acute GI toxicity: grade 2+ (during RT)
9.2
9.2. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 2: Acute GI toxicity: grade 1+ (during RT)
9.3
9.3. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 3: Diarrhoea grade 2+(during RT)
9.4
9.4. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 4: Diarrhoea grade 2+(up to 3 months)
9.5
9.5. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 5: Rectal bleeding grade 2+ (during RT)
9.6
9.6. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 6: Rectal bleeding grade 2+ (up to 3 months)
9.7
9.7. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 7: Pain/cramps grade 2+(during RT)
9.8
9.8. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 8: Pain/cramps grade 2+(up to 3 months)
9.9
9.9. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 9: Tenesmus grade 2+(during RT)
9.10
9.10. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 10: Tenesmus grade 2+(up to 3 months)
9.11
9.11. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 11: Vomiting grade 2+(during RT)
9.12
9.12. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 12: Medication for GI symptom control
9.13
9.13. Analysis
Comparison 9: Aminosalicylates vs placebo, Outcome 13: Discontinuation of study medication
10.1
10.1. Analysis
Comparison 10: Corticosteroids vs placebo, Outcome 1: Acute GI toxicity: grade 2+
10.2
10.2. Analysis
Comparison 10: Corticosteroids vs placebo, Outcome 2: Late GI toxicity: grade 2+
10.3
10.3. Analysis
Comparison 10: Corticosteroids vs placebo, Outcome 3: Late GI toxicity: grade 1+
10.4
10.4. Analysis
Comparison 10: Corticosteroids vs placebo, Outcome 4: Diarrhoea: grade 2+ (up to 12 months)
10.5
10.5. Analysis
Comparison 10: Corticosteroids vs placebo, Outcome 5: Rectal bleeding (up to 12 months, ungraded)
10.6
10.6. Analysis
Comparison 10: Corticosteroids vs placebo, Outcome 6: Faecal urgency (up to 12 months, ungraded)
11.1
11.1. Analysis
Comparison 11: Superoxide dismutase vs no intervention, Outcome 1: Acute GI toxicity: grade 2+ (3 months)
11.2
11.2. Analysis
Comparison 11: Superoxide dismutase vs no intervention, Outcome 2: Late GI toxicity: grade 2+ (1 year)
11.3
11.3. Analysis
Comparison 11: Superoxide dismutase vs no intervention, Outcome 3: Late GI toxicity: grade 2+ (2 years)
12.1
12.1. Analysis
Comparison 12: Amifostine vs no intervention, Outcome 1: Acute GI toxicity: grade 2+(during RT)
12.2
12.2. Analysis
Comparison 12: Amifostine vs no intervention, Outcome 2: Acute GI toxicity: grade 2+(up to 3 months)
12.3
12.3. Analysis
Comparison 12: Amifostine vs no intervention, Outcome 3: Acute GI toxicity: grade 1+(up to 3 months)
12.4
12.4. Analysis
Comparison 12: Amifostine vs no intervention, Outcome 4: Late GI toxicity: grade 2+
12.5
12.5. Analysis
Comparison 12: Amifostine vs no intervention, Outcome 5: Late GI toxicity: grade 1+
12.6
12.6. Analysis
Comparison 12: Amifostine vs no intervention, Outcome 6: Diarrhoea grade 2+ (during treatment)
12.7
12.7. Analysis
Comparison 12: Amifostine vs no intervention, Outcome 7: Discontinuation of RT
13.1
13.1. Analysis
Comparison 13: Bile acid sequestrants vs no intervention, Outcome 1: GI symptom scores
13.2
13.2. Analysis
Comparison 13: Bile acid sequestrants vs no intervention, Outcome 2: Acute GI toxicity: grade 2+ (during RT)
13.3
13.3. Analysis
Comparison 13: Bile acid sequestrants vs no intervention, Outcome 3: Diarrhoea: grade 2+ (during RT)
13.4
13.4. Analysis
Comparison 13: Bile acid sequestrants vs no intervention, Outcome 4: Medication for symptom control
14.1
14.1. Analysis
Comparison 14: Magnesium oxide vs placebo, Outcome 1: Acute GI toxicity: grade 2+ (during RT)
14.2
14.2. Analysis
Comparison 14: Magnesium oxide vs placebo, Outcome 2: Medication for symptom control
14.3
14.3. Analysis
Comparison 14: Magnesium oxide vs placebo, Outcome 3: Discontinuation of study medication
15.1
15.1. Analysis
Comparison 15: Misoprostol vs placebo, Outcome 1: Acute GI toxicity: grade 2+ (during RT)
15.2
15.2. Analysis
Comparison 15: Misoprostol vs placebo, Outcome 2: Diarrhoea grade 2+ (during RT)
15.3
15.3. Analysis
Comparison 15: Misoprostol vs placebo, Outcome 3: Diarrhoea grade 2+ (1+ years post‐RT)
15.4
15.4. Analysis
Comparison 15: Misoprostol vs placebo, Outcome 4: Rectal bleeding grade 2+ (during RT)
15.5
15.5. Analysis
Comparison 15: Misoprostol vs placebo, Outcome 5: Rectal bleeding grade 2+ (1+ years post‐RT)
15.6
15.6. Analysis
Comparison 15: Misoprostol vs placebo, Outcome 6: Tenesmus 2+ (during RT)
15.7
15.7. Analysis
Comparison 15: Misoprostol vs placebo, Outcome 7: Tenesmus 2+ (1+ years post‐RT)
15.8
15.8. Analysis
Comparison 15: Misoprostol vs placebo, Outcome 8: Faecal urgency 2+ (during RT)
15.9
15.9. Analysis
Comparison 15: Misoprostol vs placebo, Outcome 9: Faecal incontinence (1+ years post‐RT)
15.10
15.10. Analysis
Comparison 15: Misoprostol vs placebo, Outcome 10: Pain/cramps 2+ (during RT)
16.1
16.1. Analysis
Comparison 16: Octreotide vs placebo, Outcome 1: Diarrhoea grade 2+ (acute)
16.2
16.2. Analysis
Comparison 16: Octreotide vs placebo, Outcome 2: Rectal bleeding grade 2+ (acute)
16.3
16.3. Analysis
Comparison 16: Octreotide vs placebo, Outcome 3: Tenesmus grade 2+ (during RT)
16.4
16.4. Analysis
Comparison 16: Octreotide vs placebo, Outcome 4: Vomiting grade 2+ (during RT)
16.5
16.5. Analysis
Comparison 16: Octreotide vs placebo, Outcome 5: Pain/cramps grade 2+ (during RT)
16.6
16.6. Analysis
Comparison 16: Octreotide vs placebo, Outcome 6: Faecal incontinence grade 2+ (during RT)
16.7
16.7. Analysis
Comparison 16: Octreotide vs placebo, Outcome 7: Medication for GI symptom control
16.8
16.8. Analysis
Comparison 16: Octreotide vs placebo, Outcome 8: Discontinuation of study medication
17.1
17.1. Analysis
Comparison 17: Selenium vs no intervention, Outcome 1: Diarrhoea grade 2+ (acute)
18.1
18.1. Analysis
Comparison 18: Sodium butyrate enema vs placebo, Outcome 1: Acute GI toxicity grade 2+ (during RT)
18.2
18.2. Analysis
Comparison 18: Sodium butyrate enema vs placebo, Outcome 2: Acute GI toxicity grade 1+ (during RT)
19.1
19.1. Analysis
Comparison 19: Sucralfate vs placebo, Outcome 1: Acute GI toxicity: grade 2+(during RT)
19.2
19.2. Analysis
Comparison 19: Sucralfate vs placebo, Outcome 2: Acute GI toxicity: grade 1+ (during RT)
19.3
19.3. Analysis
Comparison 19: Sucralfate vs placebo, Outcome 3: Late GI toxicity: grade 2+
19.4
19.4. Analysis
Comparison 19: Sucralfate vs placebo, Outcome 4: Diarrhoea grade 2+ (during RT)
19.5
19.5. Analysis
Comparison 19: Sucralfate vs placebo, Outcome 5: Rectal bleeding grade 2+(during RT)
19.6
19.6. Analysis
Comparison 19: Sucralfate vs placebo, Outcome 6: Pain/cramps grade 2+(during RT)
19.7
19.7. Analysis
Comparison 19: Sucralfate vs placebo, Outcome 7: Faecal urgency grade 2+ (during RT)
19.8
19.8. Analysis
Comparison 19: Sucralfate vs placebo, Outcome 8: Faecal incontinence grade 2+(during RT)
19.9
19.9. Analysis
Comparison 19: Sucralfate vs placebo, Outcome 9: Tenesmus grade 2+(during RT)
19.10
19.10. Analysis
Comparison 19: Sucralfate vs placebo, Outcome 10: Medication for symptom control
19.11
19.11. Analysis
Comparison 19: Sucralfate vs placebo, Outcome 11: Discontinuation of study medication
20.1
20.1. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 1: Acute GI toxicity: grade 2+ (during RT)
20.2
20.2. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 2: Acute GI toxicity: grade 1+ (during RT)
20.3
20.3. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 3: Late GI toxicity: grade 1+
20.4
20.4. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 4: Diarrhoea grade 1+ (during RT)
20.5
20.5. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 5: Diarrhoea grade 2+ (during RT)
20.6
20.6. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 6: GI symptom score (during RT)
20.7
20.7. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 7: GI symptom score (1 year after RT)
20.8
20.8. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 8: GI symptom score ‐ mean change from baseline (at end of RT)
20.9
20.9. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 9: GI symptom score ‐ mean change from baseline (1 year after RT)
20.10
20.10. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 10: RT discontinuation
20.11
20.11. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 11: QoL (during RT)
20.12
20.12. Analysis
Comparison 20: Diet vs control (usual on‐treatment diet), Outcome 12: QoL (1 year after RT)
21.1
21.1. Analysis
Comparison 21: Counselling vs no intervention, Outcome 1: GI symptom score (acute)
21.2
21.2. Analysis
Comparison 21: Counselling vs no intervention, Outcome 2: Diarrhoea: grade 2+ (end of RT)
21.3
21.3. Analysis
Comparison 21: Counselling vs no intervention, Outcome 3: Diarrhoea grade 2+ (3 months post‐RT)
21.4
21.4. Analysis
Comparison 21: Counselling vs no intervention, Outcome 4: Diarrhoea grade 2+ (5 years post‐RT)
21.5
21.5. Analysis
Comparison 21: Counselling vs no intervention, Outcome 5: Weight loss: grade 2+ (end of RT)
21.6
21.6. Analysis
Comparison 21: Counselling vs no intervention, Outcome 6: Weight loss: grade 2+ (3 months post‐RT)
21.7
21.7. Analysis
Comparison 21: Counselling vs no intervention, Outcome 7: Vomiting: grade 2+ (end of RT)
21.8
21.8. Analysis
Comparison 21: Counselling vs no intervention, Outcome 8: Vomiting: grade 2+ (3 months post‐RT)
21.9
21.9. Analysis
Comparison 21: Counselling vs no intervention, Outcome 9: Medication for symptom control (end of RT)
21.10
21.10. Analysis
Comparison 21: Counselling vs no intervention, Outcome 10: Medication for symptom control (3 months post‐RT)
21.11
21.11. Analysis
Comparison 21: Counselling vs no intervention, Outcome 11: QOL
22.1
22.1. Analysis
Comparison 22: Protein supplement vs no intervention, Outcome 1: Diarrhoea: grade 2+ (end of RT)
22.2
22.2. Analysis
Comparison 22: Protein supplement vs no intervention, Outcome 2: Diarrhoea grade 2+ (3 months post‐RT)
22.3
22.3. Analysis
Comparison 22: Protein supplement vs no intervention, Outcome 3: Diarrhoea grade 2+ (5 years post‐RT)
22.4
22.4. Analysis
Comparison 22: Protein supplement vs no intervention, Outcome 4: Vomiting: grade 2+ (end of RT)
22.5
22.5. Analysis
Comparison 22: Protein supplement vs no intervention, Outcome 5: Vomiting: grade 2+ (3 months post‐RT)
22.6
22.6. Analysis
Comparison 22: Protein supplement vs no intervention, Outcome 6: Weight loss: grade 2+ (end of RT)
22.7
22.7. Analysis
Comparison 22: Protein supplement vs no intervention, Outcome 7: Weight loss: grade 2+ (3 months post‐RT)
22.8
22.8. Analysis
Comparison 22: Protein supplement vs no intervention, Outcome 8: Medication for symptom control (end of RT)
22.9
22.9. Analysis
Comparison 22: Protein supplement vs no intervention, Outcome 9: Medication for symptom control (3 months post‐RT)
23.1
23.1. Analysis
Comparison 23: Glutamine vs placebo, Outcome 1: Acute GI toxicity: grade 2+(during RT)
23.2
23.2. Analysis
Comparison 23: Glutamine vs placebo, Outcome 2: Acute GI toxicity: grade 1+ (during RT)
23.3
23.3. Analysis
Comparison 23: Glutamine vs placebo, Outcome 3: Late GI toxicity: grade 2+ (1 year)
23.4
23.4. Analysis
Comparison 23: Glutamine vs placebo, Outcome 4: Late GI toxicity: grade 1+ (1 year)
23.5
23.5. Analysis
Comparison 23: Glutamine vs placebo, Outcome 5: Diarrhoea grade 2+(during RT)
23.6
23.6. Analysis
Comparison 23: Glutamine vs placebo, Outcome 6: Tenesmus grade 2+(during RT)
23.7
23.7. Analysis
Comparison 23: Glutamine vs placebo, Outcome 7: Pain/cramps grade 2+(during RT)
23.8
23.8. Analysis
Comparison 23: Glutamine vs placebo, Outcome 8: Rectal bleeding grade 2+ (during RT)
23.9
23.9. Analysis
Comparison 23: Glutamine vs placebo, Outcome 9: Vomiting grade 2+ (during RT)
23.10
23.10. Analysis
Comparison 23: Glutamine vs placebo, Outcome 10: Nausea grade 2+ (during RT)
23.11
23.11. Analysis
Comparison 23: Glutamine vs placebo, Outcome 11: Medication for GI symptom control
23.12
23.12. Analysis
Comparison 23: Glutamine vs placebo, Outcome 12: Faecal incontinence (during RT)
23.13
23.13. Analysis
Comparison 23: Glutamine vs placebo, Outcome 13: Faecal incontinence (1 year post RT)
23.14
23.14. Analysis
Comparison 23: Glutamine vs placebo, Outcome 14: Faecal incontinence (2 year post RT)
23.15
23.15. Analysis
Comparison 23: Glutamine vs placebo, Outcome 15: Pain/cramps grade 2+(during RT)
23.16
23.16. Analysis
Comparison 23: Glutamine vs placebo, Outcome 16: Pain/cramps grade 2+(1 year post RT)
23.17
23.17. Analysis
Comparison 23: Glutamine vs placebo, Outcome 17: Pain/cramps grade 2+(2 year post RT)
23.18
23.18. Analysis
Comparison 23: Glutamine vs placebo, Outcome 18: Rectal bleeding grade 2+ (1 year post RT)
23.19
23.19. Analysis
Comparison 23: Glutamine vs placebo, Outcome 19: Rectal bleeding grade 2+ (2 year post RT)
24.1
24.1. Analysis
Comparison 24: Probiotics vs control (placebo or no intervention), Outcome 1: Diarrhoea: grade 2+ (during RT)
24.2
24.2. Analysis
Comparison 24: Probiotics vs control (placebo or no intervention), Outcome 2: Weight loss grade 2+
24.3
24.3. Analysis
Comparison 24: Probiotics vs control (placebo or no intervention), Outcome 3: Medication for GI symptom control
25.1
25.1. Analysis
Comparison 25: Proteolytic enzymes vs control (placebo or no intervention), Outcome 1: Acute GI toxicity: grade 2+ (during RT)
25.2
25.2. Analysis
Comparison 25: Proteolytic enzymes vs control (placebo or no intervention), Outcome 2: Acute GI toxicity: grade 1+ (during RT)
25.3
25.3. Analysis
Comparison 25: Proteolytic enzymes vs control (placebo or no intervention), Outcome 3: Diarrhoea: grade 2+ (during RT)
25.4
25.4. Analysis
Comparison 25: Proteolytic enzymes vs control (placebo or no intervention), Outcome 4: Vomiting grade 2+ (during RT)
25.5
25.5. Analysis
Comparison 25: Proteolytic enzymes vs control (placebo or no intervention), Outcome 5: Rectal bleeding grade 2+ (during RT)
25.6
25.6. Analysis
Comparison 25: Proteolytic enzymes vs control (placebo or no intervention), Outcome 6: Medication for GI symptom control
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD012529

References

References to studies included in this review

Ahmad 2010 {published data only}
    1. Ahmad IU, Forman JD, Sarkar FH, Hillman GG, Health E , Vaishampayan U, et al. Soy isoflavones in conjunction with radiation therapy in patients with prostate cancer. Nutrition and Cancer 2010;62(7):996-1000. - PMC - PubMed
Arafat 2016 {published data only}
    1. Arafat W, Darwish A, El Hussiny G. Comparison between standard and reduced volume radiotherapy in bladder preservation trimodality protocol for muscle invasive bladder cancer patient. Annals of Oncology 2012;37th ESMO Congress. 2012 September 28-October 2nd; Vienna Austria:ix265. - PMC - PubMed
    1. Arafat W, Darwish A, Naoum GE, Sameh W, El Husseiny G, Abd-El-Gawad F, et al. Comparison between standard and reduced volume radiotherapy in bladder preservation trimodality protocol for muscle-invasive bladder cancer patients. Ecancermedicalscience; www.ncbi.nlm.nih.gov/pmc/articles/PMC5102689/ 2016;10:682; eCollection 2016. - PMC - PubMed
Arregui Lopez 2012 {published data only}
    1. Arregui López E, Bueno Serrano C, Quintana Navarro G, Rodríguez Liñán M, Béjar Luque A, Rivín del Campo E, et al. Steady diet as prophylaxis of acute diarrhea in preoperative pelvic radiotherapy of rectal adenocarcinoma. Radiotherapy and Oncology 2012;Annual Conference of the European Society for Radiotherapy and Oncology, ESTRO 31. 2012 May 9-13; Barcelona, Spain:S109.
    1. Lopez AE, Serrano BC, Navarro QG, Linan RM, Luque BA, Rivin del Campo E, et al. Steady diet as prophylaxis of acute diarrhea in preoperative pelvic radiotherapy of rectal adenocarcinoma. Reports of Practical Oncology and Radiotherapy 2013;17th Meeting of the Radiation Oncology Spanish Society, SEOR 2013. 2013 June 18-21; Vigo Spain:S111.
Athanassiou 2003 {published data only}
    1. Athanassiou H, Antonadou D, Coliarakis N, Kouveli A, Synodinou M, Paraskevaidis M, et al. Protective effect of amifostine during fractionated radiotherapy in patients with pelvic carcinomas: results of a randomized trial. International Journal of Radiation Oncology, Biology, Physics 2003;56(4):1154-60. - PubMed
Baughan 1993 {published data only}
    1. Baughan CA, Canney PA, Buchanan RB, Pickering RM. A randomized trial to assess the efficacy of 5-aminosalicylic acid for the prevention of radiation enteritis. Clinical Oncology (Royal College of Radiologists) 1993;5(1):19-24. - PubMed
Botten 2015 {published data only}
    1. Botten RJ, DiMatteo AC, Sharma KG, Dinning PG, Higgs B, Fraser RJ, et al. Endorectal balloon (ERB) during image guided radiation therapy (IGRT) for carcinoma of the prostate (CAP) reduces gastrointestinal (GI) dysfunction and improves health related quality of life (HRQOL) scores at 1 year. Gastroenterology 2015;148(4 SUPPL. 1):S297.
Chang 2016 {published data only}
    1. Chang L, Li L, Li W, Jiang M, Jv Y, Wang L, et al. Research on radiotherapy at different times of the day for inoperable cervical cancer. International Journal of Clinical Pharmacology and Therapeutics 2016;54(11):856-64. - PubMed
Chary 1984 {published data only}
    1. Chary S, Thomson DH. A clinical trial evaluating cholestyramine to prevent diarrhea in patients maintained on low-fat diets during pelvic radiation therapy. International Journal of Radiation Oncology, Biology, Physics 1984;10(10):1885-90. - PubMed
Chitapanarux 2010 {published data only}
    1. Chitapanarux I, Chitapanarux T, Traisathit P, Kudumpee S, Tharavichitkul E, Lorvidhaya V. Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients. Radiation Oncology (London, England) 2010;5:31. - PMC - PubMed
Chopra 2015 {published data only}
    1. Chopra S, Engineer R, Mahantshetty U, Misra S, Phurailatpam R, Paul SN, et al. Protocol for a phase III randomised trial of image-guided intensity modulated radiotherapy (IG-IMRT) and conventional radiotherapy for late small bowel toxicity reduction after postoperative adjuvant radiation in Ca cervix. BMJ Open 2012;2(6):pii: e001896. - PMC - PubMed
    1. Chopra S, Engineer R, Mahantshetty UM, Dora T, Kannan S, Phurailatpam R, et al. Phase III RCT of postoperative adjuvant conventional radiation (3DCRT) versus IGIMRT for reducing late bowel toxicity in cervical cancer (PARCER) (NCT01279135/CTRI2012/120349): Results of interim analyses. International Journal of Radiation Oncology, Biology, Physics 2015;57th Annual Meeting of the American Society for Radiation Oncology, ASTRO 2015 October 18-21:S4.
Dale 2001 {published data only}
    1. Dale PS, Tamhankar CP, George D, Daftary GV. Co-medication with hydrolytic enzymes in radiation therapy of uterine cervix: evidence of the reduction of acute side effects. Cancer Chemotherapy and Pharmacology 2001;47 Suppl:S29-34. - PubMed
Dearnaley 1999 {published data only}
    1. Dearnaley DP, Khoo VS, Norman AR, Meyer L, Nahum A, Tait D, et al. Comparison of radiation side-effects of conformal and conventional radiotherapy in prostate cancer: a randomised trial. Lancet 1999;353(9149):267-72. - PubMed
Delia 2007 {published data only}
    1. Delia P, Sansotta G, Donato V, Frosina P, Messina G, De Renzis C, et al. Use of probiotics for prevention of radiation-induced diarrhea. World Journal of Gastroenterology 2007;13(6):912-5. - PMC - PubMed
    1. Delia P, Sansotta G, Donato V, Frosina P, Salatino A, Messina G, et al. Use of probiotics for prevention of radiation-induced diarrhea. Tumori 2007;93(2):suppl 1-6. - PubMed
    1. Delia P, Sansotta G, Donato V, Messina G, Frosina P, Pergolizzi S, et al. Prevention of radiation-induced diarrhea with the use of VSL#3, a new high-potency probiotic preparation. American Journal of Gastroenterology 2002;97(8):2150-2. - PubMed
De Maria 1992 {published data only}
    1. De Maria D, Falchi AM, Venturino P. Adjuvant radiotherapy of the pelvis with or without reduced glutathione: a randomized trial in patients operated on for endometrial cancer. Tumori 1992;78(6):374-6. - PubMed
Demers 2014 {published data only}
    1. Demers M, Dagnault A, Desjardins J. A randomized double-blind controlled trial: impact of probiotics on diarrhea in patients treated with pelvic radiation. Clinical Nutrition 2014;33(5):761-7. - PubMed
    1. Germain I, Desjardins J, Demers M, Dagnault A. Phase III study: Impact of probiotics on diarrhea in patients treated with pelvic radiation. International Journal of Radiation Oncology, Biology, Physics 2011;53rd Annual Meeting of the American Society for Radiation Oncology, ASTRO 2011 October 2-6 2; Miami Beach, FL USA:S667-8.
Emami 2014 {published data only}
    1. Emami H, Nikoobin F, Roayaei M, Ziya HR. Double-blinded, randomized, placebo-controlled study to evaluate the effectiveness of green tea in preventing acute gastrointestinal complications due to radiotherapy. Journal of Research in Medical Sciences 2014;19(5):445-50. - PMC - PubMed
Esco 2004 {published data only}
    1. Esco R, Valencia J, Coronel P, Carceller JA, Gimeno M, Bascon N. Efficacy of orgotein in prevention of late side effects of pelvic irradiation: a randomized study. International Journal of Radiation Oncology, Biology, Physics 2004;60(4):1211-9. - PubMed
Fuccio 2011 {published data only}
    1. Fuccio L, Alessandra G, Liboria L, Cennamo V, Cecconi L, Cecconi A, et al. Topical rectal beclometasone dypropionate for the prevention of radiation-induced proctopathy: a prospective, randomized, double-blind, placebo controlled, endoscopy-based study. Radiotherapy and Oncology 2010;European Society for Therapeutic Radiology and Oncology, ESTRO 29, 2010 September 12-16; Barcelona Spain:S197.
    1. Fuccio L, Guido A, Laterza L, Eusebi LH, Busutti L, Bunkheila F, Barbieri E, et al. Preventive treatment with topical rectal beclo-methasone dipropionate reduces post-radiation risk of bleeding in patients irradiated for prostate cancer: A randomized controlled trial. Digestive and Liver Disease 2011;17th National Congress of Digestive Diseases - Italian Federation of Societies of Digestive Diseases, FISMAD, 2011 March 5-9; Turin Italy:S133-4.
    1. Fuccio L, Guido A, Laterza L, Eusebi LH, Busutti L, Bunkheila F, Barbieri E, et al. Randomised clinical trial: preventive treatment with topical rectal beclomethasone dipropionate reduces post-radiation risk of bleeding in patients irradiated for prostate cancer. Alimentary Pharmacology & Therapeutics 2011;34(6):628-37. - PubMed
Gandhi 2013 {published data only}
    1. Gandhi AK, Rath GK, Sharma DN, Sharma S, Kumar S, Thulkar S, et al. Chronic gastrointestinal toxicity in locally-advanced carcinoma cervix treated with intensity modulated versus conventional pelvic radiation therapy: Results from a prospective randomized study. International Journal of Radiation Oncology, Biology, Physics 2103;55th Annual Meeting of the American Society for Radiation Oncology, ASTRO 2013, September 22-25; Atlanta, GA USA:S32-3. - PubMed
    1. Gandhi AK, Rath GK, Sharma DN, Subramani V, Sharma S, Manigandan D, et al. Acute gastrointestinal and genitourinary toxicities in locally advanced carcinoma cervix treated with intensity modulated versus conventional pelvic radiation therapy: Results from a prospective randomized study. In: International Journal of Radiation Oncology, Biology, Physics. Vol. 54th Annual Meeting of the American Society for Radiation Oncology, ASTRO 2012, October 28-31; Boston, MA USA. 2012:S436. - PubMed
    1. Gandhi AK, Rath GK, Sharma DN, Subramani V, Sharma S, Manigandan D, et al. Early clinical outcomes of intensity modulated versus conventional pelvic radiation therapy for locally advanced carcinoma cervix: a prospective randomized study. In: International Journal of Radiation Oncology, Biology, Physics. Vol. 54th Annual Meeting of the American Society for Radiation Oncology, ASTRO 2012, October 28-31; Boston, MA USA. 2012:S17-8. - PubMed
    1. Gandhi AK, Sharma DN, Rath GK, Julka PK, Subramani V, Sharma S, et al. Early clinical outcomes and toxicity of intensity modulated versus conventional pelvic radiation therapy for locally advanced cervix carcinoma: a prospective randomized study. International Journal of Radiation Oncology, Biology, Physics 2013;87(3):542-8. - PubMed
    1. Gandhi AK, Sharma DN, Rath GK, Julka PK, Subramani V, Sharma S, et al. Long-term clinical outcome and late toxicity of intensity modulated versus conventional pelvic radiation therapy for locally advanced cervix carcinoma: updated results from a prospective randomized study. International Journal of Radiation Oncology, Biology, Physics 2015;57th Annual Meeting of the American Society for Radiation Oncology, ASTRO 2015 October 18-21; San Antonio, Texas, USA:E257-8. - PubMed
Garcia‐Peris 2016 {published data only}
    1. Garcia-Peris P, Velasco C, Hernandez M, Lozano MA, Paron L, De La Cuerda C, et al. Effect of inulin and fructo-oligosaccharide on the prevention of acute radiation enteritis in patients with gynecological cancer and impact on quality-of-life: A randomized, double-blind, placebo-controlled trial. European Journal of Clinical Nutrition 2016;70(2):170-4. - PubMed
    1. Garcia-Peris P, Velasco C, Lozano MA, Moreno Y, Paron L, la Cuerda C, et al. Effect of a mixture of inulin and fructo-oligosaccharide on Lactobacillus and Bifidobacterium intestinal microbiota of patients receiving radiotherapy: a randomised, double-blind, placebo-controlled trial. Nutricion Hospitalaria 2012;27(6):1908-15. - PubMed
Gaya 2013 {published data only}
    1. Gaya A, Brulinski P, Morris SL, Ball KA, Greener AG, Corcoran S, et al. Evaluation of a Belly Board immobilisation device for rectal cancer patients receiving pre-operative chemoradiation. Journal of Radiotherapy in Practice 2013;13(4):403-9.
Giralt 2008 {published data only}
    1. Giralt J, Regadera JP, Verges R, Romero J, De la Fuente I, Biete A, et al. Effects of probiotic Lactobacillus casei DN-114 001 in prevention of radiation-induced diarrhea: results from multicenter, randomized, placebo-controlled nutritional trial. International Journal of Radiation Oncology, Biology, Physics 2008;71(4):1213-9. - PubMed
Gudipudi 2014 {published data only}
    1. Gudipudi GK, Del Priore G, Alluri KR. Comparing intensity-modulated radiotherapy and conventional external beam radiotherapy in cervical cancer. Gynecologic Oncology 2014;45th Annual Meeting on Women's Cancer of the Society of Gynecologic Oncology, SGO 2014 March 22-25; Tampa, FL USA:13.
Gupta 2009 {published data only}
    1. Gupta D, Shukla P, Bisht SS, Aggarwal A, Dhawan A, Pant MC, et al. Comparative study of efficacy, tolerability of four field box technique vs two field anterior posterior technique in locally advanced carcinoma cervix a prospective analysis: a prospective analysis. Cancer Biology & Therapy 2009;8(9):759-64. - PubMed
Habl 2016 {published data only}
    1. Habl G, Uhl M, Katayama S, Kessel KA, Hatiboglu G, Hadaschik B, et al. Acute toxicity and quality of life in patients with prostate cancer treated with protons or carbon Ions in a prospective randomized phase II study - the IPI trial. International Journal of Radiation Oncology, Biology, Physics 2016;95(1):435-43. - PubMed
Hejazi 2013 {published data only}
    1. Hejazi J, Rastmanesh R, Taleban FA, Molana SH, Ehtejab G. A pilot clinical trial of radioprotective effects of curcumin supplementation in patients with prostate cancer. Journal of Cancer Science & Therapy 2013;5(10):320-4.
Henriksson 1990 {published data only}
    1. Henriksson R, Arevarn M, Franzen L, Persson H, Stendahl U. Beneficial effects of sucralphate in radiation induced diarrhea. European Journal of Gynaecological Oncology 1990;11(4):299-302. - PubMed
Henriksson 1991 {published data only}
    1. Henriksson R, Franzen L, Littbrand B. Effects of sucralfate on acute and late bowel discomfort following radiotherapy of pelvic cancer. Journal of Clinical Oncology 1992;10(6):969-75. - PubMed
    1. Henriksson R, Franzen L, Littbrand B. Prevention and therapy of radiation-induced bowel discomfort. Scandinavian Journal of Gastroenterology 1992;191(Supplement):7-11. - PubMed
    1. Henriksson R, Franzen L, Littbrand B. Prevention of irradiation-induced bowel discomfort by sucralfate: a double-blind, placebo-controlled study when treating localized pelvic cancer. American Journal of Medicine 1991;91(2A):151S-7S. - PubMed
Hille 2005 {published data only}
    1. Hille A, Schmidberger H, Hermann RM, Christiansen H, Saile B, Pradier O, et al. A phase III randomized, placebo-controlled, double-blind study of misoprostol rectal suppositories to prevent acute radiation proctitis in patients with prostate cancer. International Journal of Radiation Oncology, Biology, Physics 2005;63(5):1488-93. - PubMed
    1. Kertesz T, Herrmann MK, Zapf A, Christiansen H, Hermann RM, Pradier O, et al. Effect of a prostaglandin--given rectally for prevention of radiation-induced acute proctitis--on late rectal toxicity. Results of a phase III randomized, placebo-controlled, double-blind study. Strahlentherapie und Onkologie 2009;185(9):596-602. - PubMed
Hombrink 2000 {published data only}
    1. Hombrink J, Frohlich D, Glatzel M, Krauss A, Thiel HJ, Meier J, et al. Prevention of radiation-induced diarrhea by smectite. Results of a double-blind randomized, placebo-controlled multicenter study. Strahlentherapie und Onkologie 2000;176(4):173-9. - PubMed
Hovdenak 2005 {published data only}
    1. Hovdenak N, Sorbye H, Dahl O. Sucralfate does not ameliorate acute radiation proctitis: randomised study and meta-analysis. Clinical Oncology (Royal College of Radiologists) 2005;17(6):485-91. - PubMed
Huddart 2013 {published data only}
    1. Huddart RA, Hall E, Hussain SA, Jenkins P, Rawlings C, Tremlett J, et al. Randomized noninferiority trial of reduced high-dose volume versus standard volume radiation therapy for muscle-invasive bladder cancer: results of the BC2001 Trial (CRUK/01/004). International Journal of Radiation Oncology, Biology, Physics 2013;87(2):261-9. - PMC - PubMed
Itoh 2015 {published data only}
    1. Itoh Y, Mizuno M, Ikeda M, Nakahara R, Kubota S, Ito J, et al. A Randomized, double-blind pilot trial of hydrolyzed rice bran versus placebo for radioprotective effect on acute gastroenteritis secondary to chemoradiotherapy in patients with cervical cancer. Evidence-Based Complementary and Alternative Medicine 2015;2015:974390. - PMC - PubMed
Jahraus 2005 {published data only}
    1. Jahraus CD, Bettenhausen D, Malik U, Sellitti M, St Clair WH. Prevention of acute radiation-induced proctosigmoiditis by balsalazide: a randomized, double-blind, placebo controlled trial in prostate cancer patients. International Journal of Radiation Oncology, Biology, Physics 2005;63(5):1483-7. - PubMed
Kardamakis 1995 {published data only}
    1. Kardamakis D, Trask CW, De Bruijn KM. A double-blind comparison study of tropisetron and placebo in the prevention of radiation-induced diarrhoea [3]. European Journal of Cancer Part a: General Topics 1995;31(5):850. - PubMed
Katsanos 2010 {published data only}
    1. Katsanos KH, Briasoulis E, Tsekeris P, Batistatou A, Bai M, Tolis C, et al. Randomized phase II exploratory study of prophylactic amifostine in cancer patients who receive radical radiotherapy to the pelvis. Journal of Experimental & Clinical Cancer Research 2010;29:68. - PMC - PubMed
Kilic 2000 {published data only}
    1. Kilic D, Egehan I, Ozenirler S, Dursun A. Double-blinded, randomized, placebo-controlled study to evaluate the effectiveness of sulphasalazine in preventing acute gastrointestinal complications due to radiotherapy. Radiotherapy and Oncology 2000;57(2):125-9. - PubMed
    1. Kilic D, Ozenirler S, Egehan I, Dursun A. Sulfasalazine decreases acute gastrointestinal complications due to pelvic radiotherapy. Annals of Pharmacotherapy 2001;35(7-8):806-10. - PubMed
Kim 2002 {published data only}
    1. Kim Y, Roscoe JA, Morrow GR. The effects of information and negative affect on severity of side effects from radiation therapy for prostate cancer. Supportive Care in Cancer 2002;10(5):416-21. - PubMed
Kneebone 2001 {published data only}
    1. Kneebone A, Mameghan H, Bolin T, Berry M, Turner S, Kearsley J, et al. Effect of oral sucralfate on late rectal injury associated with radiotherapy for prostate cancer: a double-blind, randomized trial. International Journal of Radiation Oncology, Biology, Physics 2004;60(4):1088-97. - PubMed
    1. Kneebone A, Mameghan H, Bolin T, Berry M, Turner S, Kearsley J, et al. The effect of oral sucralfate on the acute proctitis associated with prostate radiotherapy: a double-blind, randomized trial. International Journal of Radiation Oncology, Biology, Physics 2001;51(3):628-35. - PubMed
Koper 1999 {published data only}
    1. Koper PC, Jansen P, Van Putten W, Van Os M, Wijnmaalen AJ, Lebesque JV, et al. Gastro-intestinal and genito-urinary morbidity after 3D conformal radiotherapy of prostate cancer: observations of a randomized trial. Radiotherapy and Oncology 2004;73(1):1-9. - PubMed
    1. Koper PC, Stroom JC, Van Putten WL, Korevaar GA, Heijmen BJ, Wijnmaalen A, et al. Acute morbidity reduction using 3DCRT for prostate carcinoma: a randomized study. International Journal of Radiation Oncology, Biology, Physics 1999;43(4):727-34. - PubMed
Koukourakis 2000 {published data only}
    1. Koukourakis MI, Kyrias G, Kakolyris S, Kouroussis C, Frangiadaki C, Giatromanolaki A, et al. Subcutaneous administration of amifostine during fractionated radiotherapy: a randomized phase II study. Journal of Clinical Oncology 2000;18(11):2226-33. - PubMed
Kouloulias 2005 {published data only}
    1. Kouloulias VE, Kouvaris JR, Pissakas G, Kokakis JD, Antypas C, Mallas E, et al. A phase II randomized study of topical intrarectal administration of amifostine for the prevention of acute radiation-induced rectal toxicity. Strahlentherapie und Onkologie 2004;180(9):557-62. - PubMed
    1. Kouloulias VE, Kouvaris JR, Pissakas G, Mallas E, Antypas C, Kokakis JD, et al. Phase II multicenter randomized study of amifostine for prevention of acute radiation rectal toxicity: topical intrarectal versus subcutaneous application. International Journal of Radiation Oncology, Biology, Physics 2005;62(2):486-93. - PubMed
Kouvaris 2003 {published data only}
    1. Kouvaris J, Kouloulias V, Malas E, Antypas C, Kokakis J, Michopoulos S, et al. Amifostine as radioprotective agent for the rectal mucosa during irradiation of pelvic tumors. A phase II randomized study using various toxicity scales and rectosigmoidoscopy. Strahlentherapie und Onkologie 2003;179(3):167-74. - PubMed
Kozelsky 2003 {published data only}
    1. Kozelsky TF, Meyers GE, Sloan JA, Shanahan TG, Dick SJ, Moore RL, et al. Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy. Journal of Clinical Oncology 2003;21(9):1669-74. - PubMed
Lips 2011 {published data only}
    1. Lips I, Van Gils C, Kotte A, Van Leerdam M, Van Der Helde U, Van Vulpen M. A double-blind placebo-controlled randomized clinical trial with magnesium oxide to reduce prostate motion for prostate cancer radiotherapy. Radiotherapy and Oncology 2011;ESTRO Anniversary Conference:S201. - PubMed
    1. Lips IM, Van Gils CH, Kotte ANTJ, Van Leerdam ME, Franken SPG, Van Der Heide UA, et al. A double-blind placebo-controlled randomized clinical trial with magnesium oxide to reduce intrafraction prostate motion for prostate cancer radiotherapy. International Journal of Radiation Oncology, Biology and Physics 2011;82(2):653-60. - PubMed
Ljubenkovic 2002 {published data only}
    1. Ljubenkovic S. HDR brachytherapy and supervoltage external beam therapy of cervical cancer: Protection of the intestinal tract during the treatment. Archive of Oncology 2002;10(1):13-7.
Maggio 2014 {published data only}
    1. Maggio A, Magli A, Rancati T, Fiorino C, Valvo F, Fellin G, et al. Daily sodium butyrate enema for the prevention of radiation proctitis in prostate cancer patients undergoing radical radiation therapy: results of a multicenter randomized placebo-controlled dose-finding phase 2 study. International Journal of Radiation Oncology, Biology, Physics 2014;89(3):518-24. - PubMed
Manikandan 2015 {published data only}
    1. Annamalai M, Kunhiparambath H, Ma L, Dayanand S, Subhash G, Julka PK, et al. Randomized control trial between HDR brachytherapy and intensity modulated radiotherapy in localized prostate cancer: analysis of acute and late toxicity and health related quality of life. In: 2016 World Congress of Brachytherapy. 2016 June 27-29; San Francisco, CA USA. 2016:S176.
    1. Manikandan A, Laviraj MA, Haresh KP, Sharma DN, Gupta S, Mallick S, et al. Combined HDR brachytherapy and external beam radiotherapy vs external beam radiotherapy alone by IMRT in localized prostate cancer; interim analysis of acute genitourinary and gastrointestinal toxicity and biological dose volume parameters from a prospectiverandomized control trial. Brachytherapy 2015;36th Annual Meeting of the American Brachytherapy Society, ABS 2015:S53.
Manir 2014 {published data only}
    1. Manir K, Kallol B, Gaurav K, Arnab A, Amitabha M, Shaymal S. Role of glutamine versus placebo in prevention of acute gastrointestinal toxicity in pelvic radiotherapy: A randomized control study. Clinical Cancer Investigation Journal 2014;3(6):508-13.
Mansouri‐Tehrani 2016 {published data only}
    1. Mansouri-Tehrani HS, Khorasgani MR, Roayaei M. Effects of probiotics with or without honey on radiation-induced diarrhea. International Journal of Radiation Research 2016;14:205-13.
Mariados 2015 {published data only}
    1. Hamstra DA, Mariados N, Sylvester J, Shah D, Karsh L, Hudes R, et al. Continued benefit to rectal separation for prostate radiation therapy: final results of a phase III trial. Journal of Radiation Oncology, Biology, Physics 2017;97(5):976-85. - PubMed
    1. Mariados N, Sylvester J, Shah D, Karsh L, Hudes R, Beyer D, et al. Hydrogel spacer prospective multicenter randomized controlled pivotal trial: dosimetric and clinical effects of perirectal spacer application in men undergoing prostate image guided intensity modulated radiation therapy. International Journal of Radiation Oncology, Biology, Physics 2015;92(5):971-7. - PubMed
Martenson 1996 {published data only}
    1. Martenson J, Hyland G, Moertel CG, Mailliard JA, O'Fallon JR, Collins RT, et al. Olsalazine is contraindicated during pelvic radiation therapy: results of a double-blind, randomized clinical trial. International Journal of Radiation Oncology, Biology, Physics 1996;35(2):299-303. - PubMed
Martenson 2000 {published data only}
    1. Martenson JA, Bollinger JW, Sloan JA, Novotny PJ, Urias RE, Michalak JC, et al. Sucralfate in the prevention of treatment-induced diarrhea in patients receiving pelvic radiation therapy: A North Central Cancer Treatment Group phase III double-blind placebo-controlled trial. Journal of clinical oncology 2000;18(6):1239-45. - PubMed
Martenson 2008 {published data only}
    1. Martenson JA, Halyard MY, Sloan JA, Proulx GM, Miller RC, Deming RL, et al. Phase III, double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy: results of North Central Cancer Treatment Group N00CA. Journal of clinical oncology 2008;26(32):5248-53. - PMC - PubMed
Martin 2002 {published data only}
    1. Martin T, Uhder K, Kurek R, Roeddiger S, Schneider L, Vogt HG, et al. Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial. Radiotherapy and Oncology 2002;65(1):17-22. - PubMed
McGough 2008 {published data only}
    1. McGough C, Wedlake L, Baldwin C, Hackett C, Norman AR, Blake P, et al. Clinical trial: normal diet vs. partial replacement with oral E028 formula for the prevention of gastrointestinal toxicity in cancer patients undergoing pelvic radiotherapy. Alimentary Pharmacology & Therapeutics 2008;27(11):1132-9. - PubMed
McGuffin 2016 {published data only}
    1. McGuffin M, Devji N, Dugas L, Carty A, Russell S, Prospero L, et al. To prep or not to prep: That is the question. Journal of medical imaging and radiation sciences Conference: 12th Annual Radiation Therapy Conference, rti3 2016 March 4-5; Toronto, ON Canada;47(1 SUPPL):S9.
Menander‐Huber 1978 {published data only}
    1. Edsmyr F, Huber W, Menander KB. Orgotein efficacy in ameliorating side effects due to radiation therapy. Double-blind, placebo-controlled trial in patients with bladder tumors. Current Therapeutic Research, Clinical and Experimental 1976;19(2):198-211. - PubMed
    1. Edsmyr F, Menander-Huber KB. Orgotein efficacy in ameliorating side effects due to radiation therapy. European Journal of Rheumatology and Inflammation 1981;4(2):228-36. - PubMed
    1. Menander-Huber KB, Edsmyr F, Huber W. Orgotein (superoxide dismutase): a drug for the amelioration of radiation-induced side effects. A double-blind, placebo-controlled study in patients with bladder tumours. Urological Research 1978;6(4):255-7. - PubMed
Miller 2016 {published data only}
    1. Iott MJ. Primary and secondary endpoint analysis of N08C9 (Alliance): A phase III randomized study of sulfasalazine versus placebo in the prevention of acute radiation enteritis. Journal of Clinical Oncology 2015 Gastrointestinal Cancers Symposium. January 15; San Francisco, CA USA;33(3 SUPPL 1):no pagination.
    1. Miller RC, Petereit DG, Sloan JA, Liu H, Martenson JA, Bearden JD, et al. N08C9 (alliance): A phase 3 randomized study of sulfasalazine versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy. International journal of Radiation Oncology, Biology, Physics 2016: 55th Annual Meeting of the American Society for Radiation Oncology, 2013 September 22; Atlanta, GA, USA;95(4):1168-74. - PMC - PubMed
    1. Miller RC, Petereit DG, Sloan JA, Liu H, Martenson JA, Bearden JD, et al. N08C9 (Alliance)-a phase 3 randomized study of sulfasalazine versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy. International Journal of Radiation Oncology, biology, physics 2013;87(5):1186-7. - PMC - PubMed
    1. Miller RC, Petereit DG, Sloan JA, Liu H, Martenson JA, Bearden JD, et al. Primary and secondary endpoint analysis of n08c9 (alliance): A phase 3 randomized trial of sulfasalazine versus placebo in the prevention of acute radiation enteritis. International Journal of Radiation Oncology, Biology, Physics 2014;56th Annual Meeting of the American Society for Radiation Oncology, ASTRO 2014. September 14-17; San Francisco, CA USA:S86. - PMC - PubMed
Muecke 2010 {published data only}
    1. Muecke R, Glatzel M, Riesenbeck D, Bernd-Skorka R, Seifert G, Buntzel J, et al. Sodium selenite in gynecologic radiation oncology - first results of a phase III study. Trace Elements and Electrolytes 2004;21(2):78-82.
    1. Muecke R, Micke O, Schomburg L, Buentzel J, Glatzel M, Baaske D, et al. Impact of the planning volume (PTV) size on radiation-induced diarrhea following selenium supplementation - A subgroup analysis of the multicenter phase-III trial. In: Anticancer Research. Vol. 1996. 15th International Hamburg Symposium on Tumor Markers. 2011 May 29-31; Hamburg, Germany:S76.
    1. Muecke R, Micke O, Schomburg L, Buentzel J, Glatzel M, Baaske D, et al. Impact of treatment planning target volumen (PTV) size on radiation induced diarrhoea following selenium supplementation in gynecologic radiation oncology - a subgroup analysis of a multicenter, phase III trial. Radiation Oncology 2013;8:72. - PMC - PubMed
    1. Muecke R, Micke O, Schomburg L, Glatzel M, Reichl B, Kisters K, et al. Multicenter, phase III trial comparing selenium supplementation with observation in gynecologic radiation oncology: follow-up analysis of the survival data 6 years after cessation of randomization. Integrative Cancer Therapies 2014;13(6):463-7. - PubMed
    1. Muecke R, Schomburg L, Glatzel M, Berndt-Skorka R, Baaske D, Reichl B, et al. Multicenter, phase 3 trial comparing selenium supplementation with observation in gynecologic radiation oncology. International Journal of Radiation Oncology, Biology, Physics 2010;78(3):828-35. - PubMed
Mullaney 2014 {published data only}
    1. Mullaney L, Thirion P, Coffey M. The impact of rectal and bladder preparation in prostate radiotherapy. Radiotherapy and Oncology 2011;ESTRO Anniversary Conference.
    1. Mullaney LM, O'Shea E, Dunne MT, Finn MA, Thirion PG, Cleary LA, et al. A randomized trial comparing bladder volume consistency during fractionated prostate radiation therapy. Practical Radiation Oncology 2014;4(5):e203-12. - PubMed
Murphy 2000 {published data only}
    1. Murphy J, Stacey D, Crook J, Thompson B, Panetta D. Testing control of radiation-induced diarrhea with a psyllium bulking agent: a pilot study. Canadian Oncology Nursing Journal 2000;10(3):96-100. - PubMed
Naik 2016 {published data only}
    1. Naik A, Gurjar OP, Gupta KL, Singh K, Nag P, Bhandari V. Comparison of dosimetric parameters and acute toxicity of intensity-modulated and three-dimensional radiotherapy in patients with cervix carcinoma: A randomized prospective study. Cancer Radiotherapie 2016;20:370-6. - PubMed
Nascimento 2014 {published data only}
    1. Nascimento M, Aguilar-Nascimento JE, Caporossi C, Castro-Barcellos HM, Motta RT. Efficacy of synbiotics to reduce acute radiation proctitis symptoms and improve quality of life: a randomized, double-blind, placebo-controlled pilot trial. International Journal of Radiation Oncology, Biology, Physics 2014;90(2):289-95. - PubMed
Nout 2009 {published data only}
    1. De Boer SM, Nout RA, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, Van der Steen-Banasik EM, et al. Long-term impact of endometrial cancer diagnosis and treatment on health-related quality of life and cancer survivorship: results from the randomized PORTEC-2 trial. International Journal of Radiation Oncology, Biology, Physics 2015;93(4):797-809. - PubMed
    1. Nout RA, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens L, Van Der Steen-Banasik EM, et al. Five-year quality of life of endometrial cancer patients treated in the randomised Post Operative Radiation Therapy in Endometrial Cancer (PORTEC-2) trial and comparison with norm data. European Journal of Cancer 2012;48(11):1638-48. - PubMed
    1. Nout RA, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, Van der Steen-Banasik EM, et al. Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: first results of the randomized PORTEC-2 trial. Journal of Clinical Oncology 2009;27(21):3547-56. - PubMed
    1. Nout RA, Smit VT, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, et al. Vaginal brachytherapy versus pelvic external beam radiotherapy for patients with endometrial cancer of high-intermediate risk (PORTEC-2): an open-label, non-inferiority, randomised trial. Lancet 2010;375(9717):816-23. - PubMed
O'Brien 1997 {published data only}
    1. O'Brien PC, Franklin CI, Dear KB, Hamilton CC, Poulsen M, Joseph DJ, et al. A phase III double-blind randomised study of rectal sucralfate suspension in the prevention of acute radiation proctitis. Radiotherapy and Oncology 1997;45(2):117-23. - PubMed
    1. O'Brien PC, Franklin CI, Poulsen MG, Joseph DJ, Spry NS, Denham JW. Acute symptoms, not rectally administered sucralfate, predict for late radiation proctitis: longer term follow-up of a phase III trial--Trans-Tasman Radiation Oncology Group. International Journal of Radiation Oncology, Biology, Physics 2002;54(2):442-9. - PubMed
Pal 2013 {published data only}
    1. Basu J, Bhattacharya B, Pal S. A prospective randomized controlled trial to study the role of sulfasalazine in prevention of acute gastro-intestinal toxicity associated with concurrent chemoradiation in carcinoma cervix. In: Journal of Cancer Research and Therapeutics. Vol. 34th Annual Conference of the Association of Radiation Oncologists of India, AROICON 2012 November 29 - December 2; Kolkata India. 2012:S153.
    1. Pal S, Adhikary SS, Bhattacharya B, Basu J, Ghosh T, Patra NB. A prospective randomized controlled trial to study the role of sulfasalazine in prevention of acute gastrointestinal toxicity associated with concurrent chemoradiation in carcinoma cervix. Clinical Cancer Investigation Journal 2013;2(2):118-21.
Pettersson 2012 {published data only}
    1. Pettersson A, Johansson B, Persson C, Berglund A, Turesson I. Effects of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life: a randomized controlled trial in prostate cancer patients undergoing radiotherapy. Radiotherapy and Oncology 2012;103(3):333-40. - PubMed
    1. Pettersson A, Nygren P, Persson C, Berglund A, Turesson I, Johansson B. Effects of a dietary intervention on gastrointestinal symptoms after prostate cancer radiotherapy: long-term results from a randomized controlled trial. Radiotherapy and Oncology 2014;113(2):240-7. - PubMed
Prada 2009 {published data only}
    1. Prada PJ, Gonzalez H, Menendez C, Llaneza A, Fernandez J, Santamarta E, et al. Transperineal injection of hyaluronic acid in the anterior perirectal fat to decrease rectal toxicity from radiation delivered with low-dose-rate brachytherapy for prostate cancer patients. Brachytherapy 2009;8(2):210-7. - PubMed
Ravasco 2005 {published data only}
    1. Ravasco P, Monteiro-Grillo I, Camilo M. Individualized nutrition intervention is of major benefit to colorectal cancer patients: Long-term follow-up of a randomized controlled trial of nutritional therapy. American Journal of Clinical Nutrition 2012;96(6):1346-53. - PubMed
    1. Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. Journal of Clinical Oncology 2005;23(7):1431-8. - PubMed
Razzaghdoust 2014 {published data only}
    1. Razzaghdoust A, Mozdarani H, Mofid B. Famotidine as a radioprotector for rectal mucosa in prostate cancer patients treated with radiotherapy. Phase I/II randomized placebo-controlled trial. Strahlentherapie und Onkologie 2014;190(8):739-44. - PubMed
Resbeut 1997 {published data only}
    1. Resbeut M, Marteau P, Cowen D, Richaud P, Bourdin S, Dubois JB, et al. A randomized double blind placebo controlled multicenter study of mesalazine for the prevention of acute radiation enteritis. Radiotherapy and Oncology 1997;44(1):59-63. - PubMed
Rotovnik Kozjek 2011 {published data only}
    1. Rotovnik Kozjek N, Kompan L, Soeters P, Oblak I, Mlakar Mastnak D, Mozina B, et al. Oral glutamine supplementation during preoperative radiochemotherapy in patients with rectal cancer: a randomised double blinded, placebo controlled pilot study. Clinical Nutrition 2011;30(5):567-70. - PubMed
Salminen 1988 {published data only}
    1. Salminen E, Elomaa I, Minkkinen J, Vapaatalo H, Salminen S. Preservation of intestinal integrity during radiotherapy using live Lactobacillus acidophilus cultures. Clinical Radiology 1988;39(4):435-7. - PubMed
Sanguineti 2003 {published data only}
    1. Sanguineti G, Franzone P, Marcenaro M, Foppiano F, Vitale V. Sucralfate versus mesalazine versus hydrocortisone in the prevention of acute radiation proctitis during conformal radiotherapy for prostate carcinoma. A randomized study. Strahlentherapie und Onkologie 2003;179(7):464-70. - PubMed
Shukla 2010 {published data only}
    1. Shukla P, Gupta D, Bisht SS, Pant MC, Bhatt ML, Gupta R, et al. Circadian variation in radiation-induced intestinal mucositis in patients with cervical carcinoma. Cancer 2010;116(8):2031-5. - PubMed
Sidik 2007 {published data only}
    1. Sidik S, Hardjodisastro D, Setiabudy R, Gondowiardjo S. Does hyperbaric oxygen administration decrease side effect and improve quality of life after pelvic radiation? Acta Medica Indonesiana 2007;39(4):169-73. - PubMed
Stellermans 2002 {published data only}
    1. Stellamans K, Lievens Y, Lambin P, Van den Weyngaert D, Van den Bogaert W, Scalliet P, et al. Does sucralfate reduce early side effects of pelvic radiation? A double-blind randomized trial. Radiotherapy and Oncology 2002;65(2):105-8. - PubMed
Stryker 1979 {published data only}
    1. Stryker JA, Demers LM, Mortel R. Prophylactic ibuprofen administration during pelvic irradiation. International Journal of Radiation Oncology, Biology, Physics 1979;5(11-12):2049-52. - PubMed
Stryker 1983 {published data only}
    1. Stryker JA, Chung CK, Layser JD. Colestipol hydrochloride prophylaxis of diarrhea during pelvic radiotherapy. International Journal of Radiation Oncology, Biology, Physics 1983;9(2):185-90. - PubMed
Stryker 1986 {published data only}
    1. Stryker JA, Bartholomew M. Failure of lactose-restricted diets to prevent radiation-induced diarrhea in patients undergoing whole pelvis irradiation. International journal of radiation oncology, biology, physics 1986;12(5):789-92. - PubMed
Tait 1997 {published data only}
    1. Tait DM, Nahum AE, Meyer LC, Law M, Dearnaley DP, Horwich A, et al. Acute toxicity in pelvic radiotherapy; a randomised trial of conformal versus conventional treatment. Radiotherapy and )ncology 1997;42(2):121-36. - PubMed
Timko 2010 {published data only}
    1. Timko J. Probiotics as prevention of radiation-induced diarrhoea. Journal of Radiotherapy in Practice 2010;9(4):201-8.
Valls 1991 {published data only}
    1. Valls A, Algara M, Domenech M, Llado A, Ferrer E, Marin S. Efficacy of sucralfate in the prophylaxis of diarrhea secondary to acute radiation-induced enteritis. Preliminary results of a double-blind randomized trial. Medicina Clinica 1991;96(12):449-52. - PubMed
Valls 1999 {published data only}
    1. Valls A, Pestchen I, Prats C, Pera J, Aragon G, Vidarte M, et al. Multicentric double blind clinical trial comparing sucralfate vs placebo for the prevention of diarrhoea secondary to pelvic irradiation. Medicina Clinica 1999;113(18):681-4. - PubMed
Van Lin 2007 {published data only}
    1. Van Lin EN, Kristinsson J, Philippens ME, De Jong DJ, Van der Vight LP, Kaanders JH, et al. Reduced late rectal mucosal changes after prostate three-dimensional conformal radiotherapy with endorectal balloon as observed in repeated endoscopy. International Journal of Radiation Oncology, Biology, Physics 2007;67(3):799-811. - PubMed
Viani 2016 {published data only}
    1. Viani GA, Viana BS, Martin JE, Rossi BT, Zuliani G, Stefano EJ. Intensity-modulated radiotherapy reduces toxicity with similar biochemical control compared with 3-dimensional conformal radiotherapy for prostate cancer: a randomized clinical trial. Cancer 2016;122(13):2004-11. - PubMed
Vidal‐Casariego 2014 {published data only}
    1. Vidal Casariego A, Calleja-Fernández A, Cano-Rodríguez I, Cordido-Carballido F, Ballesteros-Pomar MD. Oral glutamine during radiotherapy does not prevent subacute radiation enteritis: A randomized controlled trial. Clinical Nutrition 2013;35th European Society for Clinical Nutrition and Metabolism, ESPEN Congress:PP085.
    1. Vidal-Casariego A, Calleja-Fernandez A, Cano-Rodriguez I, Cordido F, Ballesteros-Pomar MD. Effects of oral glutamine during abdominal radiotherapy on chronic radiation enteritis: A randomized controlled trial. Nutrition 2015;31(1):200-4. - PubMed
    1. Vidal-Casariego A, Calleja-Fernandez A, De Urbina-Gonzalez JJO, Cano-Rodriguez I, Cordido F, Ballesteros-Pomar MD. Efficacy of glutamine in the prevention of acute radiation enteritis: a randomized controlled trial. Journal of Parenteral and Enteral Nutrition 2014;38(2):205-13. - PubMed
Wedlake 2012 {published data only}
    1. Wedlake L, McGough C, Klopper T, Thomas K, Lalji A, Dearnaley DP, et al. Clinical trial: Efficacy of a low or modified fat diet for the prevention of gastrointestinal toxicity in patients receiving radiotherapy treatment for pelvic malignancy. In: Radiotherapy and oncology. Vol. Conference: European Society for Therapeutic Radiology and Oncology, ESTRO 29. Barcelona Spain. 2010:S364.
    1. Wedlake LJ, McGough C, Shaw C, Klopper T, Thomas K, Lalji A, et al. Clinical trial: efficacy of a low or modified fat diet for the prevention of gastrointestinal toxicity in patients receiving radiotherapy treatment for pelvic malignancies. Journal of Human Nutrition and Dietetics 2012;25(3):247-59. - PubMed
Wedlake 2017 {published and unpublished data}
    1. Wedlake LJ, Shaw C, Lalji A, Mohammed K, Essapen S, Whelan K, et al. High fibre diet, low fibre diet or habitual diet for the prevention of radiation-induced toxicity in pelvic cancer: a multi-centre randomised controlled trial. Gut 2015;2nd Digestive Disorders Federation Conference, DDF 2015. 2015 June 22-25; London, UK:A370-1.
    1. Wedlake LJ, Shaw C, McNair H, Lalji A, Mohammed K, Klopper T, et al. Randomized controlled trial of dietary fiber for the prevention of radiation-induced gastrointestinal toxicity during pelvic radiotherapy. American Journal of Clinical Nutrition 2017:pii: ajcn150565. doi: 10.3945/ajcn.116.150565. [Epub ahead of print]. - PubMed
Yu 2015 {published data only}
    1. Yu C, Zhu W, Ji Y, Guo J, Pan P, Han J, et al. A comparative study of intensity-modulated radiotherapy and standard radiation field with concurrent chemotherapy for local advanced cervical cancer. European Journal of Gynaecological Oncology 2015;36(3):278-82. - PubMed
Zachariah 2010 {published data only}
    1. Zachariah B, Gwede CK, James J, Ajani J, Chin LJ, Donath D, et al. Octreotide acetate in prevention of chemoradiation-induced diarrhea in anorectal cancer: randomized RTOG trial. Journal of the National Cancer Institute 2010;102(8):547-56. - PMC - PubMed

References to studies excluded from this review

Akhtar 2010 {published data only}
    1. Akhtar PS, Hossain MM, Masud ZM, Ruksana N, Nahar S, Nahar L, et al. A comparative study of result of treatment of cancer cervix patients treated by two separate schedules of radiotherapy. Bangladesh Journal of Obstetetrics and Gynaecology 2010;25(2):50-8.
Al‐Mamgani 2008 {published data only}
    1. Al-Mamgani A, Van Putten WL, Heemsbergen WD, Van Leenders GJ, Slot A, Dielwart MF, et al. Update of Dutch multicenter dose-escalation trial of radiotherapy for localized prostate cancer. International Journal of Radiation Oncology, Biology, Physics 2008;72(4):980-8. - PubMed
Al‐Mamgani 2009 {published data only}
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Barnett 2011 {published data only}
    1. Barnett GC, De Meerleer G, Gulliford SL, Sydes MR, Elliott RM, Dearnaley DP. The impact of clinical factors on the development of late radiation toxicity: results from the Medical Research Council RT01 trial (ISRCTN47772397). Clinical Oncology 2011;23(9):613-24. - PubMed
Barraclough 2012 {published data only}
    1. Barraclough LH, Routledge JA, Farnell DJJ, Burns MP, Swindell R, Livsey JE, et al. Prospective analysis of patient-reported late toxicity following pelvic radiotherapy for gynaecological cancer. Radiation Oncology (London, England) 2012;103(3):327-32. - PubMed
Basu 2016 {published data only}
    1. Basu P, Jenson AB, Majhi T, Choudhury P, Mandal R, Banerjee D, et al. Phase 2 randomized controlled trial of radiation therapy plus concurrent interferon-alpha and retinoic acid versus cisplatin for stage III cervical carcinoma. International Journal of Radiation Oncology, Biology, Physics 2016;94(1):102-10. - PubMed
Becker‐Schiebe 2016 {published data only}
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Belcaro 2008 {published data only}
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Birgisson 2006 {published data only}
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Bittner 2008 {published data only}
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Boronow 1977 {published data only}
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Bossi 2016 {published data only}
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Bounous 1975 {published data only}
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Brabbins 2005 {published data only}
    1. Brabbins D, Martinez A, Yan D, Lockman D, Wallace M, Gustafson G, et al. A dose-escalation trial with the adaptive radiotherapy process as a delivery system in localized prostate cancer: analysis of chronic toxicity. International Journal of Radiation Oncology, Biology, Physics 2005;61(2):400-8. - PubMed
Brennan 2015 {published data only}
    1. Brennan V, Curran B, Mc Veigh E, Farrell S, Skourou C, Dunne M, et al. Rectal cancer: Using V-MAT with avoidance sectors and avoidance structures to reduce dose to small bowel. In: Conference: 3 ESTRO Forum. 2015 April 24-28; Barcelona Spain. 2015:S707-8.
Bruner 2015 {published data only}
    1. Bruner DW, Hunt D, Michalski JM, Bosch WR, Galvin JM, Amin M, et al. Preliminary patient-reported outcomes analysis of 3-dimensional radiation therapy versus intensity-modulated radiation therapy on the high-dose arm of the Radiation Therapy Oncology Group (RTOG) 0126 prostate cancer trial. Cancer 2015;121(14):2422-30. - PMC - PubMed
Capirci 2001 {published data only}
    1. Capirci C, Polico C, Mandoliti G. Dislocation of small bowel volume within box pelvic treatment fields, using new 'up down table' device. International Journal of Radiation Oncology, Biology, Physics 2001;51(2):465-73. - PubMed
Chen 2012 {published data only}
    1. Chen AL, Terakedis B, Williams B, Gaffney D. Clinical outcomes of 3-dimensional versus IMRT postoperative pelvic radiation for gynecologic malignancies. In: 54th Annual Meeting of the American Society for Radiation Oncology, ASTRO 2012 October 28-31; Boston, MA USA. 2012:S452.
Dische 1999 {published data only}
    1. Dische S, Saunders MI, Sealy R, Werner ID, Verma N, Foy C, et al. Carcinoma of the cervix and the use of hyperbaric oxygen with radiotherapy: A report of a randomised controlled trial. Radiotherapy and Oncology 1999;53(2):93-8. - PubMed
Dunst 2000 {published data only}
    1. Dunst J, Semlin S, Pigorsch S, Muller AC, Reese T. Intermittent use of amifostine during postoperative radiochemotherapy and acute toxicity in rectal cancer patients. Stralentherapie und Okologie 2000;176(9):416-21. - PubMed
Frøseth 2015 {published data only}
    1. Frøseth TC, Strickert T, Solli KS, Salvesen Ø, Frykholm G, Reidunsdatter RJ. A randomized study of the effect of patient positioning on setup reproducibility and dose distribution to organs at risk in radiotherapy of rectal cancer patients. Radiation Oncology (London, England) 2015;10:217. - PMC - PubMed
Fuccio 2013 {published data only}
    1. Fuccio L, Guido A. Probiotics supplementation for the prevention of gastrointestinal radiation-induced side effects: The time is now. American Journal of Gastroenterology 2013;108(2):277. - PubMed
Ghaly 2003 {published data only}
    1. Ghaly M, Wallner K, Merrick G, True L, Sutlief S, Cavanagh W, et al. The effect of supplemental beam radiation on prostate brachytherapy-related morbidity: morbidity outcomes from two prospective randomized multicenter trials. International Journal of Radiation Oncology, Biology, Physics 2003;55(5):1288-93. - PubMed
Guix 2010 {published data only}
    1. Guix B, Bartrina J M, Tello J I, Sole J, Ouinzanos L, Lacorte T, et al. Treatment of intermediate-or high-risk prostate cancer by dose escalation with high-dose 3D-conformal radiotherapy (HD-3D-CRT) or low-dose 3D-conformal radiotherapy plus HDR brachytherapy (LD-3D-CRT+HDRB): Early results of a prospective comparative trial. In: European Society for Therapeutic Radiology and Oncology, ESTRO 29. Conference Start: 2010 September 12-16; Barcelona Spain. 2010:S418.
Hamilton‐Reeves 2013 {published data only}
    1. Hamilton-Reeves JM, Banerjee S, Banerjee SK, Holzbeierlein JM, Thrasher JB, Kambhampati S, et al. Short-term soy isoflavone intervention in patients with localized prostate cancer: a randomized, double-blind, placebo-controlled trial. PLOS One 2013;8(7):e68331. [DOI: 10.1371/journal.pone.0068331] - DOI - PMC - PubMed
Ishii 2016 {published data only}
    1. Ishii K, Ogino R, Hosokawa Y, Fujioka C, Okada W, Nakahara R, et al. Comparison of dosimetric parameters and acute toxicity after whole-pelvic vs prostate-only volumetric-modulated arc therapy with daily image guidance for prostate cancer. British Journal of Radiology 2016;89:20150930. - PMC - PubMed
Kavikondala 2016 {published data only}
    1. Kavikondala M, Reddy VAP, Bhattacharya K, Upadhyay P, Seshakiren N. Validation of bone marrow sparing IMRT and comparison with standard IMRT in cervical cancer patients. In: 38th Annual Conference of the Association of Radiation Oncologists of India, AROICON 2016; India. Vol. 12. 2016:S32.
Khan 2000 {published data only}
    1. Khan AM, Birk JW, Anderson JC, Georgsson M, Park TL, Smith CJ, et al. A prospective randomized placebo-controlled double-blinded pilot study of misoprostol rectal suppositories in the prevention of acute and chronic radiation proctitis symptoms in prostate cancer patients. American Journal of Gastroenterology 2000;95(8):1961-6. - PubMed
Kilic 2012 {published data only}
    1. Kilic D, Pak Y, Oguz M. The effect of oral nutritional supplementation including epa in rectal cancer patients undergoing preoperative chemoradiotherapy (CRT). In: 34th European Society for Clinical Nutrition and Metabolism, ESPEN Congress. 2012 Serptember 8-11; Barcelona Spain. 2012:165.
Kim 2016 {published data only}
    1. Kim YJ, Park JH, Yun IH, Kim YS. A prospective comparison of acute intestinal toxicity following whole pelvic versus small field intensity-modulated radiotherapy for prostate cancer. Oncotargets and Therapy 2016;9:1319-25. - PMC - PubMed
Koizumi 2005 {published data only}
    1. Koizumi M, Nishimura T, Kagiya T. Clinical trial of adverse effect inhibition with glucosides of vitamin C and vitamin E in radiotherapy and chemotherapy. Journal of Cancer Research and Therapeutics 2005;1(4):239. - PubMed
Kucuktulu 2013 {published data only}
    1. Kucuktulu E, Guner A, Kahraman I, Topbas M, Kucuktulu U. The protective effects of glutamine on radiation-induced diarrhea. Support Care Cancer 2013;21(4):1071-5. - PubMed
Morton 2016 {published data only}
    1. Morton G, Chung HT, McGuffin M, D'Alimonte L, Zhang L, Ravi A, et al. Early patient-reported outcomes in a randomized phase II trial of HDR monotherapy in low and intermediate risk prostate cancer. Brachytherapy 2016;15(Suppl 1):S75.
Nguyen 1998 {published data only}
    1. Nguyen LN, Pollack A, Zagars GK. Late effects after radiotherapy for prostate cancer in a randomized dose-response study: results of a self-assessment questionnaire. Adult Urology 1998;51(6):991-7. - PubMed
Nout 2011 {published data only}
    1. Nout RA, Van de Poll-Franse LV, Lybeert ML, Warlam-Rodenhuis CC, Jobsen JJ, Mens JW, et al. Long-term outcome and quality of life of patients with endometrial carcinoma treated with or without pelvic radiotherapy in the post operative radiation therapy in endometrial carcinoma 1 (PORTEC-1) trial. Journal of Clinical Oncology 2011;29(13):1692-700. - PubMed
Olofsen‐Van 2001 {published data only}
    1. Olofsen-Van Acht M, Van Den Berg H, Quint S, De Boer H, Seven M, Van Somsen De Koste J, et al. Reduction of irradiated small bowel volume and accurate patient positioning by use of a bellyboard device in pelvic radiotherapy of gynecological cancer patients. Radiotherapy and Oncology 2001;59(1):87-93. - PubMed
Pollack 1996 {published data only}
    1. Pollack A, Zagars GK, Starkschall G, Childress CH, Kopplin S, Boyer AL, et al. Conventional vs. conformal radiotherapy for prostate cancer: preliminary results of dosimetry and acute toxicity. International Journal of Radiation Oncology, Biology, Physics 1996;34(3):555-64. - PubMed
Reinshagen 2012 {published data only}
    1. Reinshagen M, Hoffmann W, Classen J, Mueller R, Greinwald R, Schiebe MB. Randomised, double-blind, placebo-controlled phase ii pilot study on the efficacy and tolerability of an rectal treatment with budesonide (2MG) or placebo for the prevention of acute radiation proctitis. Gastroenterology 2012;142(5):S-182.
Restivo 2015 {published data only}
    1. Restivo A, Cocco IM, Casula G, Scintu F, Cabras F, Scartozzi M, et al. Aspirin as a neoadjuvant agent during preoperative chemoradiation for rectal cancer. British Journal of Cancer 2015;113(8):1133-9. - PMC - PubMed
Roscoe 2009 {published data only}
    1. Roscoe JA, Bushunow P, Jean-Pierre P, Heckler CE, Purnell JQ, Peppone LJ, et al. Acupressure bands are effective in reducing radiation therapy-related nausea. Journal of Pain and Symptom Management 2009;38(3):381-9. - PMC - PubMed
Sheng 2013 {published data only}
    1. Sheng X, Li D. A prospective clinical study of intensity modulated radiation therapy versus conventional radiotherapy in cervical cancer patients with postoperative pelvic recurrence. In: 18th International Meeting of the European Society of Gynaecological Oncology, ESGO 2013 October 19-22; Liverpool, UK. 2013:107.
Sirak 2014 {published data only}
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Sorbe 2012a {published data only}
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References to other published versions of this review

Lawrie 2017
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