Supporting treatment resilience with optimized nutrition and guided exercise (STRONGER) in head and neck cancer patients undergoing chemoradiation.

Abstract

TPS12161 Background: Patients with head and neck cancer (HNC) undergoing concurrent chemoradiation (chemoRT) frequently experience debilitating toxicities, including mucositis, dysphagia, fatigue, and anorexia. These treatment-related effects are associated with weight loss, sarcopenia, and functional decline, which may adversely impact treatment adherence and quality of life. Although patients commonly seek lifestyle-based supportive interventions, evidence-based, structured multimodal programs integrated during active chemoradiation remain limited. The STRONGER pilot study was designed to evaluate the feasibility and acceptability of an integrated nutrition, guided exercise, and wellness education intervention aimed at supporting treatment resilience and characterizing functional and body composition changes in this population. Methods: STRONGER is a single-arm pilot study enrolling up to 30 adult patients with biopsy-confirmed squamous cell carcinoma of the head and neck undergoing definitive or adjuvant chemoRT at Renown Health and the William N. Pennington Institute for Cancer. Eligible participants have an ECOG performance status of 0 to 2 and are able to participate in light-to-moderate physical activity. Patients with severe malnutrition, defined by Global Leadership Initiative on Malnutrition criteria and greater than 90% caloric intake via enteral feeding, or with comorbidities precluding safe exercise participation, are excluded. The 20-week multimodal intervention begins at pre-treatment baseline and continues through three months post-chemoRT, incorporating individualized nutrition counseling with calorie and protein targets informed by indirect calorimetry, twice-weekly virtual home-based resistance and mobility training with prescribed daily walking goals, and structured wellness programming, including facilitated group sessions focused on stress and fatigue management and a speech-language pathology education series. The primary objective is to assess feasibility and acceptability, defined by prespecified thresholds for recruitment, retention, and intervention adherence, as well as participant-reported acceptability measured using Likert-scaled surveys. Secondary exploratory outcomes include measures of body composition, physical function, and patient-reported quality of life and symptom burden assessed using validated instruments. Descriptive statistics and exploratory paired analyses will be used to characterize within-participant changes over time. Enrollment is ongoing. As of January 24, 2026, 2 of 30 planned participants have been enrolled. Clinical trial information: NCT07160296 .