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

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.