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Meta-Analysis
. 2011 Apr 13;2011(4):CD000978.
doi: 10.1002/14651858.CD000978.pub5.

Interventions for preventing oral mucositis for patients with cancer receiving treatment

Helen V Worthington  1 , Jan E Clarkson, Gemma Bryan, Susan Furness, Anne-Marie Glenny, Anne Littlewood, Martin G McCabe, Stefan Meyer, Tasneem Khalid
Affiliations
Meta-Analysis

Interventions for preventing oral mucositis for patients with cancer receiving treatment

Helen V Worthington et al. Cochrane Database Syst Rev. .

Abstract

Background: Treatment of cancer is increasingly more effective but is associated with short and long term side effects. Oral side effects remain a major source of illness despite the use of a variety of agents to prevent them. One of these side effects is oral mucositis (mouth ulcers).

Objectives: To evaluate the effectiveness of prophylactic agents for oral mucositis in patients with cancer receiving treatment, compared with other potentially active interventions, placebo or no treatment.

Search strategy: Electronic searches of Cochrane Oral Health Group and PaPaS Trials Registers (to 16 February 2011), CENTRAL (The Cochrane Library 2011, Issue 1), MEDLINE via OVID (1950 to 16 February 2011), EMBASE via OVID (1980 to 16 February 2011), CINAHL via EBSCO (1980 to 16 February 2011), CANCERLIT via PubMed (1950 to 16 February 2011), OpenSIGLE (1980 to 2005) and LILACS via the Virtual Health Library (1980 to 16 February 2011) were undertaken. Reference lists from relevant articles were searched and the authors of eligible trials were contacted to identify trials and obtain additional information.

Selection criteria: Randomised controlled trials of interventions to prevent oral mucositis in patients receiving treatment for cancer.

Data collection and analysis: Information regarding methods, participants, interventions, outcome measures, results and risk of bias were independently extracted, in duplicate, by two review authors. Authors were contacted for further details where these were unclear. The Cochrane Collaboration statistical guidelines were followed and risk ratios calculated using random-effects models.

Main results: A total of 131 studies with 10,514 randomised participants are now included. Overall only 8% of these studies were assessed as being at low risk of bias. Ten interventions, where there was more than one trial in the meta-analysis, showed some statistically significant evidence of a benefit (albeit sometimes weak) for either preventing or reducing the severity of mucositis, compared to either a placebo or no treatment. These ten interventions were: aloe vera, amifostine, cryotherapy, granulocyte-colony stimulating factor (G-CSF), intravenous glutamine, honey, keratinocyte growth factor, laser, polymixin/tobramycin/amphotericin (PTA) antibiotic pastille/paste and sucralfate.

Authors' conclusions: Ten interventions were found to have some benefit with regard to preventing or reducing the severity of mucositis associated with cancer treatment. The strength of the evidence was variable and implications for practice include consideration that benefits may be specific for certain cancer types and treatment. There is a need for further well designed, and conducted trials with sufficient numbers of participants to perform subgroup analyses by type of disease and chemotherapeutic agent.

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Conflict of interest statement

None known.

Figures

1
1
Risk of bias assessment graph: review authors' judgements about each risk of bias domain presented as percentages across all included studies.
2
2
Risk of bias summary: review authors' judgements about each risk of bias domain for each included study.
1.1
1.1. Analysis
Comparison 1: Allopurinol versus placebo/no treatment, Outcome 1: Mucositis (any)
1.2
1.2. Analysis
Comparison 1: Allopurinol versus placebo/no treatment, Outcome 2: Mucositis (moderate plus severe)
1.3
1.3. Analysis
Comparison 1: Allopurinol versus placebo/no treatment, Outcome 3: Mucositis (severe)
2.1
2.1. Analysis
Comparison 2: Aloe vera versus placebo, Outcome 1: Mucositis (moderate plus severe)
3.1
3.1. Analysis
Comparison 3: Amifostine versus placebo/no treatment, Outcome 1: Mucositis (any)
3.2
3.2. Analysis
Comparison 3: Amifostine versus placebo/no treatment, Outcome 2: Mucositis (moderate plus severe)
3.3
3.3. Analysis
Comparison 3: Amifostine versus placebo/no treatment, Outcome 3: Mucositis (severe)
4.1
4.1. Analysis
Comparison 4: Chlorhexidine versus placebo/no treatment, Outcome 1: Mucositis (any)
4.2
4.2. Analysis
Comparison 4: Chlorhexidine versus placebo/no treatment, Outcome 2: Mucositis (moderate plus severe)
4.3
4.3. Analysis
Comparison 4: Chlorhexidine versus placebo/no treatment, Outcome 3: Mucositis (severe)
5.1
5.1. Analysis
Comparison 5: Cryotherapy versus no treatment, Outcome 1: Mucositis (any)
5.2
5.2. Analysis
Comparison 5: Cryotherapy versus no treatment, Outcome 2: Mucositis (moderate plus severe)
5.3
5.3. Analysis
Comparison 5: Cryotherapy versus no treatment, Outcome 3: Mucositis (severe)
6.1
6.1. Analysis
Comparison 6: Glutamine versus placebo, Outcome 1: Mucositis (any)
6.2
6.2. Analysis
Comparison 6: Glutamine versus placebo, Outcome 2: Mucositis (moderate plus severe)
6.3
6.3. Analysis
Comparison 6: Glutamine versus placebo, Outcome 3: Mucositis (severe)
7.1
7.1. Analysis
Comparison 7: G‐CSF versus placebo or no treatment, Outcome 1: Mucositis (any)
7.2
7.2. Analysis
Comparison 7: G‐CSF versus placebo or no treatment, Outcome 2: Mucositis (severe)
8.1
8.1. Analysis
Comparison 8: GM‐CSF versus no treatment/placebo, Outcome 1: Mucositis (any)
8.2
8.2. Analysis
Comparison 8: GM‐CSF versus no treatment/placebo, Outcome 2: Mucositis (moderate plus severe)
8.3
8.3. Analysis
Comparison 8: GM‐CSF versus no treatment/placebo, Outcome 3: Mucositis (severe)
9.1
9.1. Analysis
Comparison 9: Honey versus control, Outcome 1: Mucositis (any)
9.2
9.2. Analysis
Comparison 9: Honey versus control, Outcome 2: Mucositis (moderate plus severe)
9.3
9.3. Analysis
Comparison 9: Honey versus control, Outcome 3: Mucositis (severe)
10.1
10.1. Analysis
Comparison 10: Hydrolytic enzymes versus no treatment, Outcome 1: Mucositis (any)
10.2
10.2. Analysis
Comparison 10: Hydrolytic enzymes versus no treatment, Outcome 2: Mucositis (moderate plus severe)
11.1
11.1. Analysis
Comparison 11: Iseganan versus placebo, Outcome 1: Mucositis (moderate plus severe)
11.2
11.2. Analysis
Comparison 11: Iseganan versus placebo, Outcome 2: Mucositis (severe)
12.1
12.1. Analysis
Comparison 12: Keratinocyte GF versus placebo, Outcome 1: Mucositis (any)
12.2
12.2. Analysis
Comparison 12: Keratinocyte GF versus placebo, Outcome 2: Mucositis (moderate plus severe)
12.3
12.3. Analysis
Comparison 12: Keratinocyte GF versus placebo, Outcome 3: Mucositis (severe)
13.1
13.1. Analysis
Comparison 13: Laser versus no treatment, Outcome 1: Mucositis (any)
13.2
13.2. Analysis
Comparison 13: Laser versus no treatment, Outcome 2: Mucositis (moderate plus severe)
13.3
13.3. Analysis
Comparison 13: Laser versus no treatment, Outcome 3: Mucositis (severe)
14.1
14.1. Analysis
Comparison 14: Pilocarpine versus placebo, Outcome 1: Mucositis (any)
14.2
14.2. Analysis
Comparison 14: Pilocarpine versus placebo, Outcome 2: Mucositis (moderate plus severe)
15.1
15.1. Analysis
Comparison 15: Povidone versus water, Outcome 1: Mucositis (any)
15.2
15.2. Analysis
Comparison 15: Povidone versus water, Outcome 2: Mucositis (moderate plus severe)
15.3
15.3. Analysis
Comparison 15: Povidone versus water, Outcome 3: Mucositis (severe)
16.1
16.1. Analysis
Comparison 16: Prostaglandin versus placebo, Outcome 1: Mucositis (any)
16.2
16.2. Analysis
Comparison 16: Prostaglandin versus placebo, Outcome 2: Mucositis (severe)
17.1
17.1. Analysis
Comparison 17: PTA antibiotic pastille or paste versus placebo/no treatment, Outcome 1: Mucositis (any)
17.2
17.2. Analysis
Comparison 17: PTA antibiotic pastille or paste versus placebo/no treatment, Outcome 2: Mucositis (severe)
18.1
18.1. Analysis
Comparison 18: Radiotherapy: am versus pm, Outcome 1: Mucositis (severe)
19.1
19.1. Analysis
Comparison 19: Sucralfate versus placebo/usual care, Outcome 1: Mucositis (any)
19.2
19.2. Analysis
Comparison 19: Sucralfate versus placebo/usual care, Outcome 2: Mucositis (moderate plus severe)
19.3
19.3. Analysis
Comparison 19: Sucralfate versus placebo/usual care, Outcome 3: Mucositis (severe)
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Giles 2004 {published data only}
    1. Giles FJ, Rodriguez R, Weisdorf D, Wingard JR, Martin PJ, Fleming TR et al. A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy. Leukemia Research 2004;28(6):559-65. - PubMed
Gori 2007 {published data only}
    1. Gori E, Arpinati M, Bonifazi F, Errico A, Mega A, Alberani F et al. Cryotherapy in the prevention of oral mucositis in patients receiving low-dose methotrexate following myeloablative allogeneic stem cell transplantation: a prospective randomized study of the Gruppo Italiano Trapianto di Midollo Osseo nurses group. Bone Marrow Transplantation 2007;39(6):347-52. - PubMed
Goyal 2009 {published data only}
    1. Goyal M, Shukla P, Gupta D, Bisht SS, Dhawan A, Gupta S et al. Oral mucositis in morning vs. evening irradiated patients: a randomised prospective study. International Journal of Radiation Biology 2009;85(6):504-9. - PubMed
Gujral 2001 {published data only}
    1. Gujral MS, Patnaik PM, Kaul R, Daftary GV, Parikh HK, Tamhankar CP et al. Oral enzymes preventing side effects of radiation therapy in patients with head and neck cancers. European Journal of Cancer 1999;35 Suppl 4:168 (Abstract 634).
    1. Gujral MS, Patnaik PM, Kaul R, Parikh HK, Conradt C, Tamhankar CP et al. Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers. Cancer Chemotherapy and Pharmacology 2001;47 Suppl:S23-8. - PubMed
Haddad 2009 {published data only}
    1. Haddad R, Sonis S, Posner M, Wirth L, Costello R, Braschayko P et al. Randomised phase 2 study of concomitant chemoradiotherapy using weekly carboplatin/paclitaxel with or without daily subcutaneous amifostine in patients with locally advanced head and neck cancer. Cancer 2009;115(19):4514-23. - PubMed
Hanson 1995 {published data only}
    1. Hanson WR, Marks JE, Reddy SP, Simon S, Mihalo WE, Tova Y. Protection from radiation-induced oral mucositis by a mouth rinse containing the prostaglandin E1 analog, misoprostol: a placebo controlled double blind clinical trial. Advances in Experimental Medicine and Biology 1997;400B:811-8. - PubMed
    1. Hanson WR, Marks JE, Reddy SP, Simon S, Mihalo WE, Tova Y. Protection from radiation-induced oral mucositis by misoprostol, a prostaglandin E(1) analog: a placebo-controlled, double-blind clinical trial. American Journal of Therapeutics 1995;2(11):850-7. - PubMed
Hartmann 2001 {published data only}
    1. Hartmann J, Vangerow A, Knop S, Brugger W, Fels L, Stolte H et al. A randomized trial comparing the toxicity and the treatment costs of HD-VIC plus PBSC transplantation with or without amifostine (AMI) in patients with solid tumors. European Journal of Cancer 1999;35 Suppl 4:361 (Abstract 1464).
    1. Hartmann JT, Vangerow A, Fels LM, Knop S, Stolte H, Kanz L et al. A randomized trial of amifostine in patients with high-dose VIC chemotherapy plus autologous blood stem cell transplantation. British Journal of Cancer 2001;84(3):313-20. - PMC - PubMed
He 2008 {published data only}
    1. He Y-F, Chen J, Wang G, Sun Y-B, Wang Y, Du J-P et al. Randomised controlled trial on application of parenteral alanyl-glutamine dipeptide in chemotherapy of advanced patients with esophageal and cardiac carcinoma. Chinese Journal of Cancer Prevention and Treatment 2008;15(12):936-8.
Hu 2005 {published data only}
    1. Hu YR, Wu CQ, Liu YJ, Wang Y, Li X, Zhong H et al. Clinical observation on effect of shenqi fanghou recipe in preventing and treating radiation injury in patients with head and neck tumor. Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi 2005;25(7):623-5. - PubMed
Huang 2000 {published data only}
    1. Huang EY, Leung SW, Wang CJ, Chen HC, Sun LM, Fang FM et al. Oral glutamine to alleviate radiation-induced oral mucositis: a pilot randomized trial. International Journal of Radiation Oncology, Biology, Physics 2000;46(3):535-9. - PubMed
Huang 2003 {published data only}
    1. Huang GX, Zhao C, Han F, Zhang B, Qiu HJ, Xu BP et al. Clinical study in prophylactic use of chinese medicine to prevent chemoradiotherapy induced mucositis in nasopharyngeal carcinoma. Ai Zheng 2003;22(10):1084-7. - PubMed
Ifrah 1999 {published data only}
    1. Ifrah N, Witz F, Jouet JP, Francois S, Lamy T, Linassier C et al. Intensive short term therapy with granulocyte-macrophage-colony stimulating factor support, similar to therapy for acute myeloblastic leukemia, does not improve overall results for adults with acute lymphoblastic leukemia. American Cancer Society 1999;86(8):1496-505. - PubMed
Jebb 1994 {published and unpublished data}
    1. Jebb SA, Osborne RJ, Maughan TS, Mohideen N, Mack P, Mort D et al. 5-fluorouracil and folinic acid-induced mucositis: no effect of oral glutamine supplementation. British Journal of Cancer 1994;70(4):732-5. - PMC - PubMed
Katano 1995 {published data only}
    1. Katano M, Nakamura M, Matsuo T, Iyama A, Hisatsugu T. Effect of granulocyte colony-stimulating factor (G-CSF) on chemotherapy-induced oral mucositis. Surgery Today 1995;25(3):202-6. - PMC - PubMed
Kaul 1999 {published data only}
    1. Kaul R, Mishra BK, Sutradar P, Choudhary V, Gujral MS. The role of Wobe-Mugos in reducing acute sequele of radiation in head and neck cancers - a clinical phase-III randomized trial. Indian Journal of Cancer 1999;36(2-4):141-8. - PubMed
    1. Kaul RVC. To evaluate the effect of Wobe mugos hydrolytic enzyme therapy on inflammation induced by external radiotherapy in patients of head and neck cancers. Bahrain Medical Bulletin 2001;23(3):116-8.
Kazemian 2009 {published data only}
    1. Kazemian A, Kamian S, Aghili M, Hashemi FA, Haddad P. Benzydamine for prophylaxis of radiation-induced oral mucositis in head and neck cancers: a double-blind placebo-controlled randomized clinical trial. European Journal of Cancer Care 2009;18(2):174-8. - 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
Labar 1993 {published data only}
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Leborgne 1997 {published and unpublished data}
    1. Leborgne JH, Leborgne F, Zubizarreta E, Ortega B, Mezzera J. Corticosteroids and radiation mucositis in head and neck cancer. A double-blind placebo-controlled randomized trial. Radiotherapy and Oncology 1997;47(2):145-8. - PubMed
Li 2006 {published data only}
    1. Li Y, Yu Z, Liu F, Tan L, Wu B, Li J. Oral glutamine ameliorates chemotherapy-induced changes of intestinal permeability and does not interfere with the antitumor effect of chemotherapy in patients with breast cancer: a prospective randomized trial. Tumori 2006;92(5):396-401. - PubMed
Lievens 1998 {published data only}
    1. Lievens Y, Haustermans K, den Weyngaert D, den Bogaert W, Scalliet P, Hutsebaut L et al. Does sucralfate reduce the acute side-effects in head and neck cancer treated with radiotherapy? A double-blind randomized trial. Radiotherapy and Oncology 1998;47(2):149-53. - PubMed
Lilleby 2006 {published data only}
    1. Lilleby K, Garcia P, Gooley T, McDonnnell P, Taber R, Holmberg L et al. A prospective, randomized study of cryotherapy during administration of high-dose melphalan to decrease the severity and duration of oral mucositis in patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation. Bone Marrow Transplantation 2006;37(11):1031-5. - PubMed
Lin 2006 {published data only}
    1. Lin J, Wang X, Fan Z. A study on quantizing evaluation on stomatitis of malignant tumor patients undergoing large dose of chemotherapy. Chinese Nursing Research 2008;22(2A):328-9.
    1. Lin LC, Que J, Lin LK, Lin FC. Zinc supplementation to improve mucositis and dermatitis in patients after radiotherapy for head-and-neck cancers: a double-blind, randomized study. International Journal of Radiation Oncology, Biology, Physics 2006;65(3):745-50. - PubMed
Lockhart 2005 {published data only}
    1. Lockhart PB, Brennan MT, Kent ML, Packman CH, Norton HJ, Fox PC et al. Randomized controlled trial of pilocarpine hydrochloride for the moderation of oral mucositis during autologous blood stem cell transplantation. Bone Marrow Transplantation 2005;35(7):713-20. - PubMed
Loprinzi 1990 {published and unpublished data}
    1. Dose AM, Loprinzi CL, Cianflone S, Etzell P, Burnham N, Therneau T. A controlled evaluation of an allopurinol mouthwash as prophylaxis against 5-fluorouracil-induced stomatitis. A North Central Cancer Treatment Group and Mayo clinic study. In: Proceedings of the American Society of Clinical Oncology. Vol. 8. 1989:341 (Abstract 1328). - PubMed
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Madan 2008 {published data only}
    1. Madan PD, Sequeira PS, Shenoy K, Shetty J. The effect of three mouthwashes on radiation-induced oral mucositis in patients with head and neck malignancies: a randomized control trial. Journal of Cancer Research and Therapeutics 2008;4(1):3-8. - PubMed
Mahood 1991 {published data only}
    1. Mahood DJ, Dose AM, Loprinzi CL, Veeder MH, Athmann LM, Thereau TM et al. Inhibition of fluorouracil-induced stomatitis by oral cryotherapy. Journal of Clinical Oncology 1991;9(3):449-52. - PubMed
Makkonen 1994 {published data only}
    1. Makkonen TA, Bostrom P, Vilja P, Joensuu H. Sucralfate mouth washing in the prevention of radiation-induced mucositis: A placebo-controlled double-blind randomized study. International Journal of Radiation Oncology, Biology, Physics 1994;30(1):177-82. - PubMed
Makkonen 2000 {published data only}
    1. Makkonen TA, Minn H, Jekunen A, Vilja P, Tuominen J, Joeensuu H. Granulocyte Macrophage-colony stimulating factor (GM-CSF) and sucralfate in prevention of radiation-induced mucositis: a prospective randomized study. International Journal of Radiation Oncology, Biology, Physics 2000;46(3):525-34. - PubMed
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McAleese 2006 {published data only}
    1. McAleese JJ, Bishop KM, A'Hern R, Henk JM. Randomized phase II study of GM-CSF to reduce mucositis caused by accelerated radiotherapy of laryngeal cancer. The British Journal of Radiology 2006;79(943):608-13. - PubMed
McGaw 1985 {published data only}
    1. McGaw WT, Belch A. Oral complications of acute leukemia: prophylactic impact of a chlorhexidine mouth rinse regimen. Oral Surgery, Oral Medicine, and Oral Pathology 1985;60(3):275-80. - PubMed
Meropol 2003 {published data only}
    1. Meropol NJ, Somer RA, Gutheil J, Pelley RJ, Modiano MR, Rowinsky EK et al. Randomized phase I trial of recombinant human keratinocyte growth factor plus chemotherapy: potential role as mucosal protectant. Journal of Clinical Oncology 2003;21(8):1452-8. - PubMed
Mills 1988 {published data only}
    1. Mills EE. The modifying effect of beta-carotene on radiation and chemotherapy induced oral mucositis. British Journal of Cancer 1988;57(4):416-7. - PMC - PubMed
Motallebnejad 2008 {published and unpublished data}
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Nemunaitis 1995 {published data only}
    1. Nemunaitis J, Rosenfeld CS, Ash R, Freedman MH, Deeg HJ, Appelbaum F et al. Phase III randomized, double-blind placebo-controlled trial of rhGM-CSF following allogeneic bone marrow transplantation. Bone Marrow Transplantation 1995;15(6):949-54. - PubMed
Nottage 2003 {published data only}
    1. Nottage M, McLachlan SA, Brittain MA, Oza A, Hedley D, Feld R et al. Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: a randomized, placebo-controlled trial. Supportive Care in Cancer 2003;11(1):41-7. - PubMed
Oberbaum 2001 {published data only}
    1. Oberbaum M, Yaniv I, Ben-Gal Y, Stein J, Ben-Zvi N, Freedman LS et al. A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation. American Cancer Society 2001;92(3):684-90. - PubMed
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Okuno 1999 {published data only}
    1. Okuno SH, Swan L, Ebbert C. Phase III placebo-controlled clinical trial evaluation of glutamine for decreasing mucositis in patients receiving 5 FU (Fluorouracil)-based chemotherapy. In: Proceedings of the Annual Meeting of the American Society of Clinical Oncology. 1998:256.
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Panahi 2009 {published data only}
    1. Panahi Y, Ala S, Saeedi M, Okhovatian A, Bazzaz N, Naghizadeh MM. Allopurinol mouth rinse for prophylaxis of fluorouracil-induced mucositis. European Journal of Cancer Care 2010;19(3):308-12. - PubMed
Peterson 2009 {published data only}
    1. Barker NP, Peterson DE, Akhmadullina LI, Rodionova I, Sherman NZ, Gertner JM et al. Prophylaxis of recurrent chemotherapy-induced oral mucositis: a phase II multicenter, randomized, placebo-controlled trial of recombinant human intestinal trefoil factor (rhITF). Journal of Clinical Oncology 2008;26:505 (Abstract 9514).
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Pfeiffer 1990 {published data only}
    1. Pfeiffer P, Hansen SO, Madsen EL, May O. Sucralfate prophylaxis of chemotherapy-induced stomatitis. In: Proceedings of the American Society of Clinical Oncology. Vol. 8. 1989:171 (Abstract 665).
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Pillsbury 1986 {published data only}
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Pitten 2003 {published data only}
    1. Pitten FA, Kiefer T, Buth C, Doelken G, Kramer A. Do cancer patients with chemotherapy-induced leukopenia benefit from an antiseptic chlorhexidine-based oral rinse? A double-blind, block-randomized, controlled study. Journal of Hospital Infection 2003;53(4):283-91. - PubMed
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Puataweepong 2009 {published data only}
    1. Puataweepong P, Dhanachai M, Dangprasert S, Sithatani C, Sawangsilp T, Narkwong L et al. The efficacy of oral aloe vera for radiation induced mucositis in head and neck cancer patients: a double-blind placebo controlled study. Asian Biomedicine 2009;3(4):375-82.
Qin 2007 {published data only}
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Rahn 1997 {published data only}
    1. Adamietz IA, Rahn R, Bottcher HD, Reimer K, Fleischer W. Prophylaxis of radiation induced oral mucositis with povidone iodine. Supportive Care in Cancer 1997;5 Suppl:165 (Abstract 48). - PubMed
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Rashad 2008 {published data only}
    1. Rashad UM, Al-Gezawy SM, El-Gezawy E, Azzaz AN. Honey as topical prophylaxis against radiochemotherapy-induced mucositis in head and neck cancer. The Journal of Laryngology and Otology 2009;123(2):223-8. - PubMed
Rocke 1993 {published data only}
    1. Dose AM, Mahood D, Loprinzi CL, Gainey D, Sorensen JM, Therneau T. A controlled trial of oral cryotherapy for preventing stomatitis in patients receiving 5- fluorouracil (5FU) plus leucovorin (LV). A North Central Cancer Treatment Group and Mayo Clinic study. In: Proceedings of the American Society of Clinical Oncology. Vol. 9. 1990:321 (Abstract 1242).
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Rosen 2006 {published data only}
    1. Rosen LS, Abdi E, Davis ID, Gutheil J, Schnell FM, Zalcberg J et al. Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy. Journal of Clinical Oncology 2006;24(33):5194-200. - PubMed
Saarilahti 2002 {published data only}
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Scarantino 2006 {published data only}
    1. Scarantino C, LeVeque F, Swann RS, White R, Schulsinger A, Hodson DI et al. Effect of pilocarpine during radiation therapy: results of RTOG 97-09, a phase III randomized study in head and neck cancer patients. The Journal of Supportive Oncology 2006;4(5):252-8. - PubMed
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Scherlacher 1990 {published data only}
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Schneider 1999 {published data only}
    1. Schneider SB, Nishimura RD, Zimmerman RP, Tran L, Shiplacoff J, Tormey M et al. Filgrastim (r-metHuG-CSF) and its potential use in the reduction of radiation-induced oropharyngeal mucositis: an interim look at a randomized, double blind, placebo-controlled trial. Cytokines, Cellular and Molecular Therapy 1999;5(3):175-80. - PubMed
Schubert 2007 {published data only}
    1. Schubert MM, Eduardo FP, Guthrie KA, Franquin JC, Bensadoun RJ, Migliorati CA et al. A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation. Supportive Care in Cancer 2007;15(10):1145-54. - PubMed
Shenep 1988 {published and unpublished data}
    1. Shenep JL, Kalwinsky DK, Hutson PR, George SL, Dodge RK, Blankenship KR et al. Efficacy of oral sucralfate suspension in prevention and treatment of chemotherapy-induced mucositis. Journal of Pediatrics 1988;113(4):758-63. - PubMed
Shieh 1997 {published data only}
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    1. Sorensen J, Skovsgaard T, Bork E, Damstrup L, Ingeberg S. Double blind, placebo-controlled randomized study of chlorhexidine prophylaxis for chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy). Journal of Clinical Oncology : ASCO annual meeting proceedings 2006;24(18S Part I):470. - PubMed
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Sornsuvit 2008 {published data only}
    1. Sornsuvit C, Komindr S, Chuncharunee S, Wanikiat P, Archararit N, Santanirand P. Pilot Study: effects of parenteral glutamine dipeptide supplementation on neutrophil functions and prevention of chemotherapy-induced side-effects in acute myeloid leukaemia patients. The Journal of International Medical Research 2008;36(6):1383-91. - PubMed
Spencer 2005 {published data only}
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Spielberger 2004 {published data only}
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Spijkervet 1989 {published data only}
    1. Spijkervet FK, Saene HK, Panders AK, Vermey A, Saene JJ, Mehta DM et al. Effect of chlorhexidine rinsing on the oropharyngeal ecology in patients with head and neck cancer who have irradiation mucositis. Oral Surgery, Oral Medicine, and Oral Pathology 1989;67(2):154-61. - PubMed
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Svanberg 2007 {published data only}
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Vacha 2003 {published data only}
    1. Vacha P, Fehlauer F, Mahlmann B, Marx M, Hinke A, Sommer K et al. Randomized phase III trial of postoperative radiochemotherapy +/- amifostine in head and neck cancer: Is there evidence for radioprotection? Strahlentherapie und Onkologie 2003;179(6):385-9. - PubMed
    1. Vacha P, Marx M, Engel A, Richter E, Feyerabend T. Side effects of postoperative radiochemotherapy with amisfostine versus radiotherapy alone in head and neck tumors. Preliminary results of a prospective randomized trial. Strahlentherapie und onkologie 1999;175 Suppl 4:18-22. - PubMed
Vadhan‐Raj 2010 {published data only}
    1. Vadhan-Raj S, Trent J, Patel S, Zhou X, Johnson MM, Araujo D et al. Single-dose palifermin prevents severe oral mucositis during multicycle chemotherapy in patients with cancer: a randomised trial. Annals of Internal Medicine 2010;153(6):358-67. - PubMed
    1. Vadhan-Raj S, Trent JC, Patel SR, Araujo DM, Ludwig LA, Bailey D et al. Randomised, double blind, placebo controlled study of palifermin for the prevention of mucositis in patients receiving doxorubicin chemotherapy. Journal of Clinical Oncology 2008:Abs No 9547.
van der Lelie 2001 {published data only}
    1. Lelie H, Thomas BL, Oers RH, Ek-Post M, Sjamsoedin SA, van Dijk-Overtoom ML et al. Effect of locally applied GM-CSF on oral mucositis after stem cell transplantation: a prospective placebo-controlled double-blind study. Annals of Hematology 2001;80(3):150-4. - PubMed
Veerasarn 2006 {published data only}
    1. Veerasarn V, Phromratanapongse P, Suntornpong N, Lorvidhaya V, Sukthomya V, Chitapanarux I et al. Effect of Amifostine to prevent radiotherapy-induced acute and late toxicity in head and neck cancer patients who had normal or mild impaired salivary gland function. Journal of the Medical Association of Thailand 2006;89(12):2056-67. - PubMed
Veness 2006 {published data only}
    1. Veness MJ, Foroudi F, Gebski V, Timms I, Sathiyaseelan Y, Cakir B et al. Use of topical misoprostol to reduce radiation-induced mucositis: results of a randomized, double-blind, placebo-controlled trial. Australasian Radiology 2006;50(5):468-74. - PubMed
Vokurka 2005 {published data only}
    1. Vokurka S, Bystricka E, Koza V, Scudlova J, Pavlicova V, Valentova D et al. The comparative effects of povidone-iodine and normal saline mouthwashes on oral mucositis in patients after high-dose chemotherapy and APBSCT--results of a randomized multicentre study. Supportive Care in Cancer 2005;13(7):554-8. - PubMed
Wahlin 1989 {published and unpublished data}
    1. Wahlin YB. Effects of chlorhexidine mouthrinse on the oral health in patients with acute leukemia. Oral Surgery, Oral Medicine, and Oral Pathology 1989;68(3):279-87. - PubMed
Wang 2002 {published data only}
    1. Wang J. Effect on Chinese herbs decoction gargling to treat and to prevent chemotherapy caused stomatitis. Chinese Nursing Research 2002;16(10):578-9.
Watanabe 2010 {published data only}
    1. Watanabe T, Ishihara M, Matsuura K, Mizuta K, Itoh Y. Polaprezinc prevents oral mucositis associated with radiochemotherapy in patients with head and neck cancer. International Journal of Cancer 2010;127(8):1984-90. - PubMed
Wijers 2001 {published data only}
    1. Wijers OB, Levendag PC, Harms ER, Gan-Teng AM, Schmitz PI, Hendriks WD et al. Mucositis reduction by selective elimination of oral flora in irradiated cancers of the head and neck: a placebo-controlled double-blind randomized study. International Journal of Radiation Oncology, Biology, Physics 2001;50(2):343-52. - PubMed
Wu 2009 {published data only}
    1. Ahn YWH, Song S, Kim Y, Oh Y, Lee C et al. The therapeutic effect of recombinant human epidermal growth factor (rhEGF) on mucositis in patients with head and neck cancer undergoing radiotherapy with or without chemotherapy: a double-blind placebo-controlled prospective phase II multi-institutional study. Journal of Clinical Oncology 2008;26:Abstract 6021. - PubMed
    1. Lee S, Song S, Kim Y, Oh Y, Lee C, Keum K, et al. The therapeutic effect of recombinant human epidermal growth factor (rhEGF) on mucositis in patients with head and neck cancer undergoing radiotherapy with or without chemotherapy: a double blind placebo controlled prospective phase II multi-institutional clinical trial. International Journal of Radiation Oncology 2008;72(1):S32. - PubMed
    1. Wu HG, Song SY, Kim YS, Oh YT, Lee CG, Keum KC et al. Therapeutic effect of recombinant human epidermal growth factor (RhEGF) on mucositis in patients undergoing radiotherapy, with or without chemotherapy, for head and neck cancer: a double-blind placebo-controlled prospective phase 2 multi-institutional clinical trial. Cancer 2009;115(16):3699-708. - PubMed
You 2009 {published data only}
    1. You WC, Hsieh CC, Huang JT. Effect of extracts from indigowood root (Isatis indigotica Fort.) on immune responses in radiation-induced mucositis. Journal of Alternative and Complementary Medicine 2009;15(7):771-8. - PubMed
Yuen 2001 {published data only}
    1. Yuen KY, Woo PCY, Tai JW, Lie AK, Luk J, Liang R. Effects of clarithromycin on oral mucositis in bone marrow transplant recipients. Haematologica 2001;86(5):554-5. - PubMed

References to studies excluded from this review

Abramoff 2008 {published data only}
    1. Abramoff MM, Lopes NN, Lopes LA, Dib LL, Guilherme A, Caran EM et al. Low-level laser therapy in the prevention and treatment of chemotherapy-induced oral mucositis in young patients. Photomedicine and Laser Surgery 2008;26(4):393-400. - PubMed
Aisa 2005 {published data only}
    1. Aisa Y, Mori T, Kudo M, Yashima T, Kondo S, Yokoyama A et al. Oral cryotherapy for the prevention of high-dose melphalan-induced stomatitis in allogeneic hematopoietic stem cell transplant recipients. Supportive Care in Cancer 2005;13(4):266-9. - PubMed
Altmann 1999 {published data only}
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Andersen 1987 {published data only}
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Anderson 1998b {published data only}
    1. Anderson PM, Ramsay NKC, Shu XO, Rydholm N, Rogosheske J, Nicklow R et al. Effect of low dose oral glutamine on painful stomatitis during bone marrow transplantation. Bone Marrow Transplantation 1998;22(4):339-44. - PubMed
Antin 2002 {published data only}
    1. Antin JH, Lee SJ, Neuberg D, Alyea E, Soiffer RJ, Sonis S et al. A phase I/II double-blind, placebo-controlled study of recombinant human interleukin-11 for mucositis and acute GVHD prevention in allogeneic stem cell transplantation. Bone Marrow Transplantation 2002;29(5):373-7. - PubMed
Antonadou 1998 {published data only}
    1. Antonadou D, Athanassiou E, Synodinou M, Koliarakis N, Panoussaki K, Karageorgis P et al. Evaluation of the efficacy of granulocyte macrophage colony stimulating factor (GM-CSF) in the prevention of radiation induced mucositis. Radiotherapy Oncology 1998;48 Suppl 1:S39.
Apaydin 1996 {published data only}
    1. Apaydin A, Karadeniz AN, Aysigi G, Blige N. The effect and therapeutical use of benzydamine HCL on radiation-induced oral cavity and oropharyngeal mucositis. Medical Bulletin Istanbul 1996;29(1):59-63.
Aquino 2005 {published data only}
    1. Aquino VM, Harvey AR, Garvin JH, Godder KT, Nieder ML, Adams RH et al. A double-blind randomized placebo-controlled study of oral glutamine in the prevention of mucositis in children undergoing hematopoietic stem cell transplantation: a pediatric blood and marrow transplant consortium study. Bone Marrow Transplantation 2005;36(7):611-6. - PubMed
Ardizzoni 2002 {published data only}
    1. Ardizzoni A, Tjan-Heijnen VC, Postmus PE, Buchholz E, Biesma B, Karnicka-Mlodkowska H, et al. Standard versus intensified chemotherapy with granulocyte colony-stimulating factor support in small-cell lung cancer: a prospective European Organization for Research and Treatment of Cancer-Lung Cancer Group Phase III Trial-08923. Journal of Clinical Oncology 2002;20(19):3947-55. - PubMed
Arora 2008 {published data only}
    1. Arora H, Pai KM, Maiya A, Vidyasagar MS, Rajeev A. Efficacy of He-Ne Laser in the prevention and treatment of radiotherapy-induced oral mucositis in oral cancer patients. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, & Endodontics 2008;105(2):180-6. - PubMed
Awada 2002 {published data only}
    1. Awada A, Biganzoli L, Cufer T, Beex L, Lohrisch C, Batter V et al. An EORTC-IDBBC phase I study of gemcitabine and continuous infusion 5-fluorouracil in patients with metastatic breast cancer resistant to anthracyclines or pre-treated with both anthracyclines and taxanes. European Journal of Cancer 2002;38(6):773-8. - PubMed
Awada 2004 {published data only}
    1. Awada A, Gil T, Sales F, Dubuisson M, Vereecken P, Klastersky J et al. Prolonged schedule of temozolomide (Temodal) plus liposomal doxorubicin (Caelyx) in advanced solid cancers. Anti-Cancer Drugs 2004;15(5):499-502. - PubMed
Awidi 2001 {published data only}
    1. Awidi A, Homsi U, Kakail RI, Mubarak A, Hassan A, Kelta M, Martinez P et al. Double-blind, placebo-controlled cross-over study of oral pilocarpine for the prevention of chemotherapy-induced oral mucositis in adult patients with cancer. European Journal of Cancer 2001;37(16):2010-4. - PubMed
Awwad 2002 {published data only}
    1. Awwad HK, Lotayef M, Shouman T, Begg AC, Wilson G, Bentzen SM et al. Accelerated hyperfractionation (AHF) compared to conventional fractionation (CF) in the postoperative radiotherapy of locally advanced head and neck cancer: influence of proliferation. British Journal of Cancer 2002;86(4):517-23. - PMC - PubMed
Barasch 1995 {published data only}
    1. Barasch A, Peterson DE, Tanzer JM, D'Ambrososio JA, Nuki K, Schubert MM et al. Helium-Neon laser effects on conditioning-induced oral mucositis in bone marrow transplantation patients. Cancer 1995;76(12):2550-6. - PubMed
Baydar 2005 {published data only}
    1. Baydar M, Dikilitas M, Sevinc A, Aydogdu I. Prevention of oral mucositis due to 5-fluorouracil treatment with oral cryotherapy. Journal of the National Medical Association 2005;97(8):1161-4. - PMC - PubMed
Bensadoun 2006 {published data only}
    1. Bensadoun RJ, Benezery K, Dassonville O, Magne N, Poissonnet G, Ramaioli A et al. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: Results at 2 years (FNCLCC-GORTEC). International Journal of Radiation Oncology, Biology, Physics 2006;64(4):983-94. - PubMed
Bentzen 2001 {published data only}
    1. Bentzen SM, Saunders MI, Dische S, Bond SJ. Radiotherapy-related early morbidity in head and neck cancer: quantitative clinical radiobiology as deduced from the CHART trial. Radiotherapy Oncology 2001;60(2):123-35. - PubMed
Bleehen 1996 {published data only}
    1. Bleehen NM, Girling DJ, Hopwood P, Lallemand G, Machin D, Stephens RJ et al. Randomised trial of four-drug vs less intensive two-drug chemotherapy in the palliative treatment of patients with small-cell lung cancer (SCLC) and poor prognosis. British Journal of Cancer 1996;73:406-13. - PMC - PubMed
Bourhis 2006 {published data only}
    1. Bourhis J, Lapeyre M, Tortochaux J, Rives M, Aghili M, Bourdin S et al. Phase III randomized trial of very accelerated radiation therapy compared with conventional radiation therapy in squamous cell head and neck cancer: a GORTEC trial. Journal of Clinical Oncology 2006;24(18):2873-8. - PubMed
Braaksma 2002 {published data only}
    1. Braaksma M, Levendag P. Tools for optimal tissue sparing in concomitant chemoradiation of advanced head and neck cancer: subcutaneous amifostine and computed tomography-based target delineation. Seminars in Oncology 2002;29(6 Supp 19):63-70. - PubMed
Buentzel 1999 {published data only}
    1. Buentzel J, Glatzel M, Weinaug R, Schuth J, Kuettner K, Froehlich D. Amifostine in combined radio- and chemomodalities for head and neck cancer. European Journal of Cancer 1999;35(Suppl 4):363 (Abs No 1472).
Calais 2000 {published data only}
    1. Calais G, Alfonsi M, Bardet E, Sire C, Germain T, Bergerot P et al. Stage III and IV cancers of the oropharynx: results of a randomized study of Gortec comparing radiotherapy alone with concomitant chemotherapy. Bulletin du Cancer 2000;87 Spec No:48-53. - PubMed
    1. Calais GM, Alfonsi E, Bardet C, Sire H, Bourgeois C, Bergerot B et al. Randomized study comparing radiation alone (RT) versus RT with concomitant chemotherapy (CT) in stages III and IV oropharynx carcinoma (ARCORO). Preliminary results of the 94.01 study from the French Group of radiation oncology for head and neck cancer (GORTEC). In: Proceedings of Annual Meeting of the American Society of Clinical Oncology. 1998:Abstract 1484.
Calais 2004 {published data only}
    1. Calais G, Bardet E, Sire C, Alfonsi M, Bourhis J, Rhein B et al. Radiotherapy with concomitant weekly docetaxel for stages III/IV oropharynx carcinoma. Results of the 98-02 GORTEC phase II trial. International Journal of Radiation, Oncology, Biology, Physics 2004;58(1):161-6. - PubMed
Cassidy 2002 {published data only}
    1. Cassidy J, Twelves C, Van Cutsem E, Hoff P, Bajetta E, Boyer M et al. First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Annals of Oncology 2002;13(4):566-75. - PubMed
Castro 2009 {published data only}
    1. Castro G Jr, Lima AG, Lopes DR, Ortegosa MV, Rosalmeida MC, Gil E et al. Oral mucositis prevention by low-level laser therapy in head and neck cancer patients submitted to concurrent chemoradiation: a prospective randomized trial. Journal of Clinical Oncology 2009;27 Suppl:15S (Abstract 6019).
Cella 2003 {published data only}
    1. Cella D, Pulliam J, Fuchs H, Miller C, Hurd D, Wingard JR et al. Evaluation of pain associated with oral mucositis during the acute period after administration of high-dose chemotherapy. Cancer 2003;98(2):406-12. - PubMed
Cheng 2001 {published data only}
    1. Cheng KK, Molassiotis A, Chang AM, Wai WC, Cheung SS. Evaluation of an oral care protocol intervention in the prevention of chemotherapy-induced oral mucositis in paediatric cancer patients. European Journal of Cancer 2001;37(16):2056-63. - PubMed
Cheng 2002 {published data only}
    1. Cheng KKF, Molassiotis A, Chang AM. An oral care protocol intervention to prevent chemotherapy-induced oral mucositis in paediatric cancer patients: a pilot study. European Journal of Oncology Nursing 2002;6(2):66-74. - PubMed
Cheng 2006 {published data only}
    1. Cheng KK-F, Yuen JKT. A pilot study of chlorhexidine and benzydamine oral rinses for the prevention and treatment of irradiation mucositis in patients with head and neck cancers. Cancer Nursing 2006;29(5):423-30. - PubMed
Clarke 2001 {published data only}
    1. Clarke SJ, Abdi E, Davis ID, Schnell FM, Zalcberg JR, Gutheil J et al. Recombinant human keratinocyte growth factor (rHuKGF) prevents chemotherapy-induced mucositis in patients with advanced colorectal cancer: a randomized phase II trial. In: Proceedings of the American Society of Clinical Oncology. Vol. 20 (Pt 1). 2001:383a (Abstract 1529).
Colella 2010 {published data only}
    1. Colella G, Cannavale R, Vicidomini A, Rinaldi G, Compilato D, Campisi G. Efficacy of a spray compound containing a pool of collagen precursor synthetic aminoacids (l-proline, l-leucine, l-lysine and glycine) combined with sodium hyaluronate to manage chemo/radiotherapy-induced oral mucositis: preliminary data of an open trial. International Journal of Immunopathology and Pharmacology 2010;23(1):143-51. - PubMed
Collova 2004 {published data only}
    1. Collova E, Castagna L, Nozza A, Perfetti V, Patrone F, Danova M et al. New approaches for reduction of oral mucositis in patients undergoing high-dose chemotherapy with hematopoietic stem cell support. Bone Marrow Transplantation 2004;33 Suppl 1:S323-4.
Colombat 1995 {published data only}
    1. Colombat P, Colin B. Comparison of fluconazole and amphotericin B in the prevention of mucositis in patients with long term aplasia. Bone Marrow Transplantation 1995;15:178.
Costa 1999 {published data only}
    1. Costa EMMB, Pinto LP, Fernandes MZ, Costa ALL. Preventing oral complications in leukemic children submitted to chemotherapy. Journal of Dental Research 1999;78:1021 (Abstract B-220).
Costa 2003 {published data only}
    1. Costa EM, Fernandes MZ, Quinder LB, Souza LB, Pinto LP. Evaluation of an oral preventive protocol in children with acute lymphoblastic leukemia. Pesquisa Odontologica Brasileira 2003;17(2):147-50. - PubMed
Cowen 1997 {published data only}
    1. Cowen D, Tardieu C, Resbeut M, Hannoun-Levi JM, Alzieu C, Schubert M et al. Low energy helium-neon laser presents oral mucositis after high-dose chemo-radiotherapy: results of a double-blind randomized trial. International Journal of Radiation Oncology, Biology, Physics 1996;36 Suppl 1:264 (Abstract 1041).
    1. Cowen D, Tardieu C, Schubert M, Peterson D, Resbeut M, Faucher C et al. Low energy Helium-neon laser in the prevention of oral mucositis in patients undergoing bone marrow transplant: results of a double blind randomized trial. International Journal of Radiation Oncology, Biology, Physics 1997;38(4):697-703. - PubMed
Cunningham 1995 {published data only}
    1. Cunningham D, Zalcberg JR, Rath U, Olver I, Cutsem EV, Sevensson C et al. 'Tomudex' (ZD1694): results of a randomised trial in advanced colorectal cancer demonstrate efficacy and reduced mucositis and leucopenia. European Journal of Cancer 1995;31A(12):1945-54. - PubMed
Damon 2004 {published data only}
    1. Damon LE, Johnston LJ, Ries CA, Rugo HS, Case D, Ault K et al. Treatment of acute leukemia with idarubicin, etoposide and cytarabine (IDEA). A randomized study of etoposide schedule. Cancer Chemotherapy and Pharmacology 2004;53(6):468-74. - PubMed
De Boer 2002 {published data only}
    1. De Boer RH, Eisen TG, Ellis PA, Johnston SR, Walsh G, Ashley S et al. A randomised phase II study of conventional versus accelerated infusional chemotherapy with granulocyte colony-stimulating factor support in advanced breast cancer. Annals of Oncology 2002;13(6):889-94. - PubMed
Denham 1999 {published data only}
    1. Denham JW, Peters LJ, Johansen J, Poulsen M, Lamb DS, Hindley A et al. Do acute mucosal reactions lead to consequential late reactions in patients with head and neck cancer? Radiotherapy and Oncology 1999;52(2):157-64. - PubMed
Djuric 2006 {published data only}
    1. Djuric M, Hillier-Kolarov V, Belic A, Jankovic L. Mucositis prevention by improved dental care in acute leukemia patients. Supportive Care in Cancer 2006;14(2):137-46. - PubMed
Dobrowsky 1998 {published data only}
    1. Dobrowsky W, Naude J, Widder J, Dobrowsky E, Millesi W, Pavelka R et al. Continuous hyperfractionated accelerated radiotherapy with/without mitomycin C in head and neck cancer. International Journal of Radiation Oncology, Biology, Physics 1998;42(4):803-6. - PubMed
Doroshow 1987 {published data only}
    1. Doroshow JH, Berthtand M, Newman E, Multhauf P, Leong L, Blayney D et al. Preliminary analysis of a randomized comparison of 5-fluorouracil versus 5-fluorouracil and high-dose continuous-infusion folinic acid in disseminated colorectal cancer. NCI Monographs 1987;5:171-4. - PubMed
Dreicer 1997 {published data only}
    1. Dreicer R, Propert KJ, Kuzel T, Kirkwood JM, O'Dwyer PJ, Loehrer PJ. A phase II trial of edatrexate in patients with advanced renal cell carcinoma. An Eastern Cooperative Oncology Group study. American Journal of Clinical Oncology 1997;20(3):251-3. - PubMed
Dudjak 1987 {published data only}
    1. Dudjak LA. Mouth care for mucositis due to radiation therapy. Cancer Nursing 1987;10(3):131-40. - PubMed
Edelman 1998 {published data only}
    1. Edelman MJ, Gandara Dr, Perez EA, Lau D, Lauder I, Turrell C et al. Phase I trial of edatrexate plus carboplatin in advanced solid tumors: amelioration of dose-limiting mucositis by ice chip cryotherapy. Investigational New Drugs 1998;16(1):69-75. - PubMed
Eisen 2003 {published data only}
    1. Eisen D, Essel J, Broun ER, Sigmund D, DeVoe M. Clinical utility of oral valacyclovir compared with oral acyclovir for the prevention of herpes simplex virus mucositis following autologous bone marrow transplantation or stem cell rescue therapy. Bone Marrow Transplantation 2003;31(1):51-5. - PubMed
El‐Sayed 2002a {published data only}
    1. El-Sayed S, Epstein J, Minish E, Burns P, Hay J, Laukkanen E. A pilot study evaluating the safety and microbiologic efficacy of an economically viable antimicrobial lozenge in patients with head and neck cancer receiving radiation therapy. Head & Neck 2002;24(1):6-15. - PubMed
    1. El-Sayed S, Nabid A, MacKenzie R, Gelinas M, Hay J, Shelley et al. Prophylaxis of radiation associated mucositis (RAM) in head and neck cancer, results of a double blind phase III trail evaluating the clinical efficacy of an antimicrobial lozenge utilizing a new validated mucositis scoring system. In: Proceedings of the 42nd Annual Meeting of the American Society for Therapeutic Radiology and Oncology. Vol. 321. 2000:Abstract 2115.
Epstein 1992 {published data only}
    1. Epstein JB, Vickars L, Spinalli J, Reece D. Efficacy of chlorhexidine and nystatin rinses in prevention of oral complications in leukemia and bone marrow transplantation. Oral Surgery, Oral Medicine, and Oral Pathology 1992;73(6):682-9. - PubMed
Erkisi 1996 {published data only}
    1. Erkisi M, Erkurt E, Ozbarlas S, Burgut R, Doran F, Seyrek E. The use of recombinant human granulocyte colony-stimulating factor in combination with single or fractionated doses of ifosfamide and doxorubicin in patients with advanced soft tissue sarcoma. Journal of Chemotherapy 1996;8(3):224-8. - PubMed
Erlichman 1988 {published data only}
    1. Erlichman C, Fine S, Wong A, Elhakim T. A randomized trial of fluorouracil and folonic acid in patients with metastatic colorectal carcinoma. Journal of Clinical Oncology 1988;6(3):469-75. - PubMed
    1. Erlichman C. Fluorouracil and leucovorin for metastatic colorectal cancer. Journal of Chemotherapy 1990;2 Suppl 1:38-40. - PubMed
Etiz 2000 {published data only}
    1. Etiz D, Erkal HS, Serin M, Kucuk B, Hepari A, Elhan AH et al. Clinical and histopathological evaluation of sucralfate in prevention of oral mucositis induced by radiation therapy in patients with head and neck malignancies. Oral Oncology 2000;36(1):116-20. - PubMed
    1. Etiz M, Erkal HS, Serin M, Kucuk B, Hepari A, Tulunay O et al. Clinicohistopathological evaluation of effectiveness of sucralfate in prevention of severe radiation-induced mucositis in patients with head and neck malignancies. Radiotherapy Oncology 1998;48 Suppl 1:S68. - PubMed
Ezzat 2005 {published data only}
    1. Ezzat M, Shouman T, Zaza K, Safwat A, El-Khoudary A, El-Senosi M et al. A randomized study of accelerated fractionation radiotherapy with and without mitomycin C in the treatment of locally advanced head and neck cancer. Journal of the Egyptian National Cancer Institute 2005;17(2):85-92. - PubMed
Fahlke 1999 {published data only}
    1. Fahlke J, Ridwelski K, Lippert H. High-dose therapy with combined 5-fluorouracil and folinic acid with and without amifostine in the treatment of patients with metastatic colorectal carcinoma. International Journal of Colorectal Disease 1999;14(2):128-30. - PubMed
Falcone 2001 {published data only}
    1. Falcone A, Allergrini G, Masi G, Lencioni M, Panner E, Brunetti I. 5-fluorouracil administered as a 48-hour chronomodulated infusion in combination with leucovorin and cisplatin: a randomized phase II study in metastatic colorectal cancer. Oncology 2001;61(1):28-35. - PubMed
Fay 1994 {published data only}
    1. Fay JW, Lazarus H, Herzig R, Saez R, Stevens DA, Collins RH Jr et al. Sequential administration of recombinant human interleukin-3 and granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for malignant lymphoma: a phase I/II multicenter study. Blood 1994;84(7):2151-7. - PubMed
Feber 1995 {published data only}
    1. Feber T. Mouth care for patients receiving oral irradiation. Professional Nurse 1995;10(10):666-70. - PubMed
Feber 1996 {published data only}
    1. Feber T. Management of mucositis in oral irradiation. Clinical Oncology 1996;8(2):106-11. - PubMed
Ferreira 2004 {published data only}
    1. Ferreira PR, Fleck JF, Diehl A, Barletta D, Braga-Filho A, Barletta A et al. Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: a double-blind randomized trial. Head & Neck 2004;26(4):313-21. - PubMed
    1. Ferreira RR, Fleck JF, Filho AB, Barletta D, Barletta A, Diehl A et al. Protective effect of vitamin E (VE) in head and neck cancer radiation induced mucositis: a double-blind randomized trial. In: Proceedings of the American Society of Clinical Oncology. Vol. 21 (Pt 1). 2002:228a.
Ferretti 1990 {published and unpublished data}
    1. Ferretti GA, Raybould TP, Brown AT, Macdonal JS, Greenwood M, Maruyama Y et al. Chlorhexidine prophylaxis for chemotherapy- and radiotherapy- induced stomatitis: a randomised double-blind trial. Oral Surgery, Oral Medicine, and Oral Pathology 1990;69(3):331-8. - PubMed
Foncuberta 2001 {published data only}
    1. Foncuberta MC, Cagnoni PJ, Brandts CH, Mandanas R, Fields K, Derigs HG et al. Topical transforming growth factor-beta3 in the prevention or alleviation of chemotherapy-induced oral mucositis in patients with lymphomas or solid tumors. Journal of Immunotherapy 2001;24(4):384-8. - PubMed
Gabison 1995 {published data only}
    1. Gabison R. Can zinc picolinate in patients receiving chemotherapy for metastatic colorectal carcinoma prevent stomatitis? European Journal of Cancer 1995;31 Suppl 6:S258 (Abstract 1234).
Gandara 1997 {published data only}
    1. Gandara DR, Edelman MJ, Crowley JJ, Lau DH, Livingston RB. Phase II trial of edatrexate plus carboplatin in metastatic non-small-cell lung cancer: a Southwest Oncology Group study. Cancer Chemotherapy and Pharmacology 1997;41(1):75-8. - PubMed
Genot‐Klastersky 2008 {published data only}
    1. Genot-Klastersky MT, Klastersky J, Awada F, Awada A, Crombez P, Martinez MD et al. The use of low-energy laser (LEL) for the prevention of chemotherapy- and/or radiotherapy-induced oral mucositis in cancer patients: results from two prospective studies. Supportive Care in Cancer 2008;16(12):1381-7. - PubMed
Ghoreishi 2007 {published data only}
    1. Ghoreishi Z, Shidfar F, Iravani M, Esfahani A, Ghavamzadeh A. Effect of vitamin E on chemotherapy-induced mucositis and neutropenia in leukemic patients undergoing bone marrow transplantation. Asia-Pacific Journal of Clinical Oncology 2007;3(3):113-8.
Giles 2003a {published data only}
    1. Giles FJ, Miller CB, Hurd DD, Wingard JR, Fleming TR, Sonis ST et al. A phase III, randomized, double-blind, placebo-controlled, multinational trial of iseganan for the prevention of oral mucositis in patients receiving stomatotoxic chemotherapy (PROMPT-CT trial). Leukemia & Lymphoma 2003;44(7):1165-72. - PubMed
Giles 2003b {published data only}
    1. Giles FJ, Faderl S, Thomas DA, Cortes JE, Garcia-Manero G, Douer D et al. Randomized phase I/II study of troxacitabine combined with cytarabine, idarubicin, or topotecan in patients with refractory myeloid leukemias. Journal of Clinical Oncology 2003;21(6):1050-6. - PubMed
Gladkov 2007 {published data only}
    1. Gladkov OA, Vazhenin AV, Sharabura TM, Kandakova E, Galiatova Iu V, Sychev VI et al. Effectiveness of different regimes of combined treatment (cisplatin+ radiotherapy) for intraoral and oropharyngeal cancer. Voprosy Onkologii 2007;53(5):575-7. - PubMed
Goldberg 2003 {published data only}
    1. Goldberg S. Safety and tolerability of en3247 in the prevention of oral mucositis associated with chemotherapy with or without total body irradiation: results of a randomized, double-blind, placebo-controlled trial. In: Proceedings of the American Society of Clinical Oncology. 2003:770.
Gordon 1993 {published data only}
    1. Gordon B, Spadinger A, Hodges E, Coccia P. Effect of granulocyte macrophage colony stimulating factor (GMCSF) on oral mucositis after autologous bone marrow transplantation. In: Proceedings of the American Society of Clinical Oncology. Vol. 12. 1993:432 (Abstract 1489). - PubMed
Grotz 2001 {published data only}
    1. Grotz KA, Henneicke-Von Zepelin HH, Kohnen R, Kutzner J, Belz GG. Prophylaxis of mucositis and dry mouth after head and neck radiotherapy. A new treatment. Krankenhauspharmazie 2002;23(5):193-8.
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Gutierrez 1996 {published data only}
    1. Gutierrez AR, Boizas EC, Carreras PS, Rodriguez CS, Rodriguez OA, Chicote MJV et al. Fluconazol as prophylaxis of radioinduced oral mucositis. Preliminary study. Oncologia 1996;19(6):56-9.
Harris 1995 {published data only}
    1. Harris JR, Russell NH, Hunter AE. Folinic acid mouthwashes do not reduce the degree of mucositis in patients undergoing allogeneic bone marrow transplantation. Bone Marrow Transplantation 1995;15(S2):S164.
He 2004 {published data only}
    1. He XY, Hu CS, Wu YR. Radioprotective effect of amifostine in nasopharyngeal carcinoma. Acta Academiae Medicinae Shanghai 2004;31(1).
Hickey 1982 {published data only}
    1. Hickey AJ, Toth BB, Lindquist SB. Effect of intravenous hyperalimentation and oral care on the development of oral stomatitis during cancer chemotherapy. The Journal of Prosthetic Dentistry 1982;47(2):188-93. - PubMed
Horsley 2007 {published data only}
    1. Horsley P, Bauer JD, Mazkowiack R, Gardner R, Bashford J. Palifermin improves severe mucositis, swallowing problems, nutrition impact symptoms, and length of stay in patients undergoing hematopoietic stem cell transplantation. Supportive Care in Cancer 2007;15(1):105-9. - PubMed
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Hu 2003 {published data only}
    1. Hu K, Ship JA, Harrison LB. Rationale for integrating high-dose rate intraoperative radiation (HDR-IORT) and postoperative external beam radiation with subcutaneous amifostine for the management of stage III/IV head and neck cancer. Seminars in Oncology 2003;30(6 Suppl 18):40-8. - PubMed
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    1. Hunter A, Mahendra P, Wilson K, Fields P, Cook G, Peniker A et al. A randomized, double-blind, placebo-controlled, multicenter trial of ATL-104, a swallowable mouthwash, in patients with oral mucositis following peripheral blood stem cell transplantation. Journal of Supportive Oncology 2007;5(4 Suppl 2):52-3.
Hwang 2004 {published data only}
    1. Hwang WY, Koh LP, Ng HJ, Tan PH, Chuah CT, Fook SC et al. A randomized trial of amifostine as a cytoprotectant for patients receiving myeloablative therapy for allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplantation 2004;34(1):51-6. - PubMed
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Jebb 1995 {published data only}
    1. Jebb SA, Marcus R, Elia M. A pilot study of oral glutamine supplementation in patients receiving bone marrow transplants. Clinical Nutrition 1995;14(3):162-5. - PubMed
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    1. Jham BC, Chen H, Carvalho AL, Freire AR. A randomized phase III prospective trial of bethanechol to prevent mucositis, candidiasis, and taste loss in patients with head and neck cancer undergoing radiotherapy: a secondary analysis. Journal of Oral Science 2009;51(4):565-72. - PubMed
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Johnson 2002 {published data only}
    1. Johnson DJ, Scott CB, Marks JE, Seay TE, Atkins JN, Berk LB et al. Assessment of quality of life and oral function of patients participating in a phase II study of radioprotection of oral and pharyngeal mucosa by the prostaglandin E(1) analog misoprostol (RTOG 96-07). International Journal of Radiation Oncology, Biology, Physics 2002;54(5):1455-9. - PubMed
Ju 2009 {published data only}
    1. Ju G-JF, Lu P-H, Wang W-X, Jiao Y-H. Effect of systematic oropharyngeal managament in prevention of acute radiation mucositis. Chinese Journal of Cancer Prevention and Treatment 2009;16(13):1031-2.
Kante 1995 {published data only}
    1. Kante V. Comparative study of two prophylactic regimes for the prevention of mucositis in autologous bone marrow transplants. Bone Marrow Transplantation 1995;15:253.
Karacetin 2004 {published data only}
    1. Karacetin D, Yucel B, Leblebicioglu B, Aksakal O, Maral O, Incekara O. A randomized trial of amifostine as radioprotector in the radiotherapy of head and neck cancer. Journal of B.U.ON. 2004;9(1):23-6. - PubMed
Karthaus 1998 {published data only}
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Khouri 2009 {published data only}
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Kuhn 2009 {published data only}
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Kuriakose 2002 {published data only}
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Labbate 2003 {published data only}
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Lanzos 2010 {published data only}
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Lavendag 1998 {published data only}
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Le 2008 {published data only}
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Lopez‐Campo 2004 {published data only}
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Lorusso 2003 {published data only}
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Luglié 2002 {published data only}
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Maddocks‐Jennings 2009 {published data only}
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Martin 2006 {published data only}
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Nicolatou‐Galitis 2006 {published data only}
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Rocci 2005 {published data only}
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Rojas 2001 {published data only}
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Rutkauskas 1993 {published data only}
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Ryu 2007 {published data only}
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Samaranayake 1988 {published data only}
    1. Samaranayake LP, Robertson AG, MacFarlane TW, Hunter IP, MacFarlane G, Soutar DS et al. The effect of chlorhexidine and benzydamine mouthwashes on mucositis induced by therapeutic irradiation. Clinical Radiology 1988;39(3):291-4. - PubMed
Sato 1997 {published data only}
    1. Sato A, Kumagai S, Sakaki K, Morikawa H, Song ST, Mori S. Inhibition of 5-fluorouracil-cisplatin-induced stomatitis by oral cryotherapy: use of an ice-bar containing fibrinolysin and deoxyribonuclease comiben (Elase). Gan to Kagaku Ryoho 1997;24(9):1135-9. - PubMed
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    1. Sato A, Saisho-Hattori T, Koizumi Y, Minegishi M, Iinuma K, Imaizumi M. Prophylaxis of mucosal toxicity by oral propantheline and cryotherapy in children with malignancies undergoing myeloablative chemo-radiotherapy. The Tohoku Journal of Experimental Medicine 2006;210(4):315-20. - PubMed
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Schwerkoske 1999 {published data only}
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Shabanloei 2009 {published data only}
    1. Shabanloei R, Ahmadi F, Vaez J, Ansarin K, Hajizadeh E, Javadzadeh Y et al. Allopurinol, chamomile and normal saline mouth washes for the prevention of chemotherapy- induced stomatitis. Journal of Clinical and Diagnostic Research 2009;3(3):1537-42.
Sharma 2009 {published data only}
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Stokman 2004 {published data only}
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References to studies awaiting assessment

Cheng 2003 {published data only}
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Yasuda 2011 {published data only}
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