Impact of Nutrition and Swallowing Function in a Randomized Controlled Trial of Head and Neck Cancer Patients During the Course of Treatment

Background: Multimodal treatment for advanced head and neck cancer (HNC) is associated with acute toxicities including mucositis, xerostomia, and dysphagia and a high prevalence of weight loss, requiring nutritional intervention. Currently, there is ongoing debate about the best way to provide nutrition support while undergoing chemoradiation (CRT) therapy after surgery for advanced head and neck cancer (HNC). Randomized controlled trials comparing the nutritional benefits of feeding tubes over dietary counseling and/or supplementation have not conclusively demonstrated a reduction in weight loss, unplanned hospitalizations, treatment toxicities, or tumour control. Additionally, the relative benefits of feeding tubes are controversial. Studies evaluating the efficacy of feeding tubes report that patients with feeding tubes have increased risk of aspiration, feeding tube dependence, a small but finite risk of tumour seeding, but more importantly long term functional swallowing impairment. However, emerging data are reporting that swallowing exercise programs that are designed to strengthen musculature throughout the course of treatment may lead to improved return of functional swallowing. Thus, preservation of functional swallowing may potentially improve return to oral nutrition.

Purpose: Our purpose of this study is to compare the efficacy of nutritional and swallowing intervention with/out a percutaneous endoscopic gastrostomy (PEG) tube to that of ad lib nutrition and swallowing counseling with/out a PEG tube in advanced HNC patients. Weight, caloric intake, instrumental swallowing function, xerostomia, mucositis, pain, unplanned treatment interruptions, unplanned hospital admissions, complications, duration of feeding tube, tumour control, performance status, and quality of life (QOL) will be assessed before, during, 3 and 6 months after CRT therapy to determine if there is any differences between the intervention groups.

Study Design: A randomized controlled longitudinal design during the entire course of treatment including surgery and CRT therapy will be conducted to investigate the efficacy of nutritional and swallowing interventions in HNC patients at baseline, after each course of consecutive course treatment and 3 and 6 month follow-up. Patients demonstrating a safe functional swallow following surgery will be randomly assigned to one of four groups: Group 1 - patients will receive PEG tube/in-depth nutrition and swallowing intervention; Group 2 - patients will receive PEG tube/ad lib nutrition and swallowing counseling; Group 3 - patients will receive in-depth nutrition and swallowing intervention; or Group 4 - patients will receive ad lib nutrition/Kaofeed tube nutrition and swallowing counseling.

Study Sample: Patients with diagnosis of HNC to the oral cavity, pharynx, and larynx undergoing surgery and CRT therapy at the University of Alberta Hospital (UAH) and Cross Cancer Institute (CCI) will be eligible for participation in the study.

Inclusion criteria are: ≥ 18 years of age; diagnosed with HNC to sites of the oral cavity, oropharynx, and larynx; all histologic types of cancer; advanced tumour stages; all forms of radiation therapy (RT) including standard or investigational for HNC; all forms of chemotherapy (CT) including standard or investigational for HNC; alert and mentally competent; English-speaking. Exclusion criteria are: unable to have safe swallow following surgical intervention; allergy or intolerance to any enteral nutritional supplements in current use; renal insufficiency. There are approximately 3-4 HNC patients scheduled for surgery, and CRT therapy per week at UAH/CCI. With a significance level of 0.01 between groups and a power of 0.85 (an effect size of 0.9) a minimum sample size of 41 patients is required for this study. As a pilot study with 20 degrees of freedom, an adequate and reasonable sample size would require 24 patients to be recruited to participate.