Multimodal intervention for sarcopenia in nasopharyngeal carcinoma patients undergoing definitive treatment: a pilot randomized controlled trial protocol

This protocol describes a pilot randomized controlled trial (RCT) designed to assess the feasibility of a multidisciplinary, multimodal intervention for sarcopenia prevention in patients with nasopharyngeal carcinoma (NPC) undergoing concurrent chemoradiotherapy (CCRT). The intervention was developed using the Medical Research Council (MRC) framework and incorporates personalized immunonutrition, structured exercise, side effect management, behavior monitoring, and guidance. This pilot trial aims to evaluate the feasibility of implementing a multimodal intervention model in this patient population. This study will be a single-site RCT including 30 patients with NPC undergoing definitive treatment. The trial will be conducted from September 2025 to May 2026 in Ningxia, China. Patients will be randomly assigned to either the intervention or control group. The intervention integrates head and neck and gastrointestinal cluster symptom management, immunonutrition management, and exercise based on the Theory of Planned Behavior. The primary outcome is feasibility, assessed through acceptability, demand, fidelity, and practicality. Secondary outcomes include changes in skeletal muscle index, sarcopenia prevalence, body composition, composite biomarkers (Global Immune-Nutrition-Inflammation Index [GINI], Hemoglobin–Albumin–Lymphocyte–Platelet Score [HALP], and Prognostic Nutritional Index [PNI]), symptom burden (Head and Neck Symptom Checklist), nutritional status (Patient-Generated Subjective Global Assessment [PG-SGA]), and adherence to exercise and dietary interventions. Exploratory outcomes include behavior change mechanisms assessed using a Theory of Planned Behavior–based questionnaire. This pilot study is designed to evaluate the feasibility of implementing a comprehensive multimodal intervention for sarcopenia in NPC patients undergoing CCRT. The outcomes will provide preliminary evidence to guide the design of future large-scale RCTs and advance multidisciplinary care models for sarcopenia management in oncology. UMIN Clinical Trials Registry, UMIN000059146.