Protocol for a randomized controlled trial of early prophylactic feeding via gastrostomy versus standard care in high risk patients with head and neck cancer

BACKGROUND: Patients with head and neck cancer are at high risk of malnutrition and dysphagia. Enteral tube feeding via a gastrostomy or nasogastric tube is often required in response to dysphagia, odynophagia or side effects of treatment that lead to dehydration and/or weight-loss. A recent systematic review concluded that the optimal method of tube feeding remains unclear; however prophylactic gastrostomy, placed in anticipation of its use during and after treatment, is common practice, following a number of demonstrated benefits. However the majority of these studies have been undertaken in patients receiving radiotherapy alone. More recent studies in patient populations receiving concurrent chemoradiotherapy are showing that despite prophylactic gastrostomy placement significant weight loss still occurs, placing the patient at risk of the consequences of malnutrition. Therefore we set out to investigate innovative prophylactic nutrition support via the gastrostomy to optimise the nutritional outcomes of patients with head and neck cancer. METHODS/DESIGN: Patients with head and neck cancer will be eligible for this single centre randomised controlled trial if they are identified for referral for a prophylactic gastrostomy using local guidelines. Patients will be excluded if they are: under the age of eighteen; pregnant; unable to give informed consent; or severely malnourished or moderately malnourished with significant dysphagia requiring a liquid or puree diet. All eligible patients who consent for the study will be allocated randomly to either the intervention or control group (usual care). The intervention group will commence prophylactic supplementary nutrition support via the gastrostomy immediately following placement compared to usual care where nutrition support is commenced via the gastrostomy when clinically indicated during treatment. Key outcome measures will be percentage weight loss, body composition, nutritional status and quality of life, measured at baseline and three months post treatment. DISCUSSION: To our knowledge this is the first study to evaluate the effectiveness of early prophylactic tube feeding compared to commencement of feeding during treatment, as per current standard practice, in patients undergoing prophylactic gastrostomy prior to treatment for head and neck cancer. TRIAL REGISTRATION: This trial has been registered in the Australian New Zealand Clinical Trials registry as ACTRN12612000579897.