Medically Tailored Meals During Radiotherapy for Head and Neck Cancer: A Pilot Randomized Controlled Trial

Weight and muscle loss in head and neck cancer (HNC) patients are common. While adequate calorie and protein intake may support maintenance, macronutrient composition remains understudied. The primary aim of this pilot randomized controlled trial was to assess the feasibility and acceptability of home-delivered, medically-tailored meals (MTMs) of a carbohydrate-restricted, high-fat (CRHF) diet versus a standard diet (SD) in newly diagnosed HNC patients undergoing radiotherapy (RT). Thirteen patients were randomized to CRHF (<i>n</i> = 6) or SD (<i>n</i> = 7). Participants received isocaloric MTMs daily for two weeks pre-RT and during RT. CRHF meals contained ∼30%-carbohydrate, 45%-fat, and 25%-protein, compared with ∼50/30/20% in SD meals. Feasibility outcomes were recruitment, retention, adherence, acceptability, and adverse events. Exploratory outcomes included descriptive changes in weight and body composition to inform future trial design. Recruitment and retention rates were 65% and 69%, respectively. MTM adherence averaged 92% in CRHF and 96% in SD. Participants reported high MTM satisfaction. CRHF participants exhibited descriptive patterns suggesting greater muscle preservation and fat loss. Higher adherence to either diet was observed with less weight loss during RT. Feasibility data suggest that a "Food is Medicine" approach may warrant further investigation in a larger trial design to assess efficacy.