Supporting Treatment Resilience With Optimized Nutrition and Guided Exercise in Head and Neck Cancer Patients Undergoing Chemoradiation

Renown Health30 enrolled

Overview

The purpose of this study to find out whether a structured lifestyle intervention-combining nutrition counseling, guided exercise, and wellness education-can help reduce treatment-related side effects and improve physical function, resilience, and quality of life in patients with head and neck cancer undergoing chemoradiation therapy (chemoRT). Benefits of research cannot be guaranteed but we hope to learn whether this intervention is feasible and acceptable during active cancer treatment, and whether it can help preserve lean body mass, improve strength and endurance, and support emotional well-being. The findings will inform the design of a future larger clinical trial.

This pilot study aims to assess the feasibility and preliminary effects of a multimodal lifestyle intervention-integrating nutrition optimization, guided exercise, and wellness education-on sarcopenia and resilience during treatment for HNC. The scope of these assessments are not experimental in nature, but will be applied in combination for this patient population as supplemental care. While the interventions are not uncommon for cancer patients, particularly as cancer patients may seek these care options independently during treatment, the participants will not be billed for these services as they are experimental in that they are not in standard treatment guidelines. This pilot study will inform the refinement of the STRONGER intervention for future use in a larger randomized controlled trial. It will test implementation logistics and provide preliminary data on intervention benefits for patients undergoing intensive cancer therapy, such as chemoRT.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Interventions

20-Week Lifestyle ProgramBEHAVIORAL

Nutrition counseling: Weekly group sessions with an oncology dietitian, including individualized calorie and protein goals. Exercise: Home-based resistance and mobility exercises twice per week using online videos, and daily walking with self-tracking. Wellness education: Weekly group sessions focused on stress management, sleep, fatigue, and mindset, facilitated by a health and wellness coach. Five of the 20 sessions will include a Speech, Voice, Swallowing, and Airway Care in Head \& Neck Cancer training series led by a speech pathologist.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults ≥18 years old with biopsy-confirmed squamous cell carcinoma of the head and neck * Planned for definitive or adjuvant chemoRT * ECOG performance status 0-2 * Ability to participate in light-to-moderate physical activity * Able to provide informed consent Exclusion Criteria: * Severe malnutrition requiring exclusive enteral feeding at baseline * Comorbidities that preclude safe participation in exercise * Cognitive or psychiatric conditions that impair study engagement

Outcomes

Primary Outcomes

Feasibility of Program: Recruitment Rate

Percentage of eligible patients who enroll in the study. Unit of Measure: Percentage (%) enrolled compared to not enrolled of eligible participants approached.

Time frame: From enrollment to the end of the intervention at 20 weeks

Program Acceptability

A five-point Likert Scale and open-ended prompts will be used to assess acceptability (see appendix) upon completion of the 20-week intervention

Time frame: From enrollment to the end of the intervention at 20 weeks

Feasibility of Program: Retention Rate

Percentage of enrolled participants who complete the 20-week intervention. Unit of Measure: Percentage (%) of participants who complete the program

Time frame: From enrollment to 20 weeks

Feasibility of Program: Session Attendance

Number of nutrition and wellness group sessions attended per participant. Unit of Measure: Count (number of sessions attended)

Time frame: Over the 20-week intervention period

Feasibility of Program: Adherence to Exercise Plan - Resistance Training

Percentage of prescribed resistance training sessions (2x/week) completed by each participant. Unit of Measure: Percentage (%) completion rate

Time frame: Over the 20-week intervention period

Feasibility of Program: Adherence to Exercise Plan - Walking Goals

Percentage of weekly walking goals met by each participant. Unit of Measure: Percentage (%) completed goals

Time frame: Over the 20-week intervention period

Feasibility of Program: Data Completeness

Percentage of participants with complete data at baseline, end of treatment, and 20-week follow-up. Unit of Measure: Percentage (%) complete data

Time frame: From baseline to 20-week follow-up

Feasibility of Program: Protocol Fidelity

Percentage of intervention components delivered as intended, per protocol. Unit of Measure: Percentage (%) delivered

Time frame: Over the 20-week intervention period

Feasibility of Program: Adverse Events

Number of safety issues reported by staff or participants during the intervention. Unit of Measure: Count (number of adverse events)

Time frame: Over the 20-week intervention period

Secondary Outcomes

Clinical Outcomes of Interest: Quality of Life

Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) at baseline and week 20. Unit of Measure: Units on a scale (0-100) Interpretation: Higher scores indicate better functioning or quality of life for functional scales; higher scores indicate worse symptoms for symptom scales.

Time frame: From enrollment to the end of the intervention at 20 weeks

Clinical Outcomes of Interest: Change in Sarcopenia Risk

Assessed using the SARC-F Questionnaire at baseline and week 20. Unit of Measure: Units on a scale (0-10) Interpretation: Higher scores indicate greater risk of sarcopenia.