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Randomized Controlled Trial
. 2017 Jun 27;117(1):15-24.
doi: 10.1038/bjc.2017.138. Epub 2017 May 23.

Randomised controlled trial of early prophylactic feeding vs standard care in patients with head and neck cancer

Teresa E Brown  1   2 , Merrilyn D Banks  2 , Brett G M Hughes  3   4 , Charles Y Lin  3   4 , Lizbeth M Kenny  3   4 , Judith D Bauer  1
Affiliations
Randomized Controlled Trial

Randomised controlled trial of early prophylactic feeding vs standard care in patients with head and neck cancer

Teresa E Brown et al. Br J Cancer. .

Abstract

Background: Weight loss remains significant in patients with head and neck cancer, despite prophylactic gastrostomy and intensive dietary counseling. The aim of this study was to improve outcomes utilising an early nutrition intervention.

Methods: Patients with head and neck cancer at a tertiary hospital in Australia referred for prophylactic gastrostomy prior to curative intent treatment were eligible for this single centre randomised controlled trial. Exclusions included severe malnutrition or dysphagia. Patients were assigned following computer-generated randomisation sequence with allocation concealment to either intervention or standard care. The intervention group commenced supplementary tube feeding immediately following tube placement. Primary outcome measure was percentage weight loss at three months post treatment.

Results: Recruitment completed June 2015 with 70 patients randomised to standard care (66 complete cases) and 61 to intervention (56 complete cases). Following intention-to-treat analysis, linear regression found no effect of the intervention on weight loss (10.9±6.6% standard care vs 10.8±5.6% intervention, P=0.930) and this remained non-significant on multivariable analysis (P=0.624). No other differences were found for quality of life or clinical outcomes. No serious adverse events were reported.

Conclusions: The early intervention did not improve outcomes, but poor adherence to nutrition recommendations impacted on potential outcomes.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
CONSORT flow diagram. Abbreviation: PEG=gastrostomy.
Figure 2
Figure 2
The effect of the early nutrition intervention on survival outcomes in patients with head and neck cancer. Kaplan–Meier curves to compare disease-free survival (A) and overall survival (B) at twelve months post-treatment between standard care and intervention groups.
See this image and copyright information in PMC

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References

    1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85: 365–376. - PubMed
    1. Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML (2010) Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med 363: 24–35. - PMC - PubMed
    1. Bauer J, Capra S, Ferguson M (2002) Use of the scored patient-generated subjective global assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr 56: 779–785. - PubMed
    1. Beer KT, Krause KB, Zuercher T, Stanga Z (2005) Early percutaneous endoscopic gastrostomy insertion maintains nutritional state in patients with aerodigestive tract cancer. Nutr Cancer 52: 29–34. - PubMed
    1. Brown T, Banks M, Hughes B, Kenny L, Lin C, Bauer J (2014) Protocol for a randomized controlled trial of early prophylactic feeding via gastrostomy versus standard care in high risk patients with head and neck cancer. BMC Nurs 13: 17. - PMC - PubMed

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