Multimodal intervention for sarcopenia in nasopharyngeal carcinoma patients undergoing definitive treatment: a pilot randomized controlled trial protocol.
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Abstract
BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: UMIN Clinical Trials Registry, UMIN000059146.
期刊介绍：
Nutrition Journal publishes surveillance, epidemiologic, and intervention research that sheds light on i) influences (e.g., familial, environmental) on eating patterns; ii) associations between eating patterns and health, and iii) strategies to improve eating patterns among populations. The journal also welcomes manuscripts reporting on the psychometric properties (e.g., validity, reliability) and feasibility of methods (e.g., for assessing dietary intake) for human nutrition research. In addition, study protocols for controlled trials and cohort studies, with an emphasis on methods for assessing dietary exposures and outcomes as well as intervention components, will be considered.
Manuscripts that consider eating patterns holistically, as opposed to solely reductionist approaches that focus on specific dietary components in isolation, are encouraged. Also encouraged are papers that take a holistic or systems perspective in attempting to understand possible compensatory and differential effects of nutrition interventions. The journal does not consider animal studies.
In addition to the influence of eating patterns for human health, we also invite research providing insights into the environmental sustainability of dietary practices. Again, a holistic perspective is encouraged, for example, through the consideration of how eating patterns might maximize both human and planetary health.
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