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

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer

• Registration Number: NCT07160296
• Lead Sponsor: Renown Health

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Study Start: 2025-09-15
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Program: Recruitment Rate	From enrollment to the end of the intervention at 20 weeks	Percentage of eligible patients who enroll in the study. Unit of Measure: Percentage (%) enrolled compared to not enrolled of eligible participants approached.
Program Acceptability	From enrollment to the end of the intervention at 20 weeks	A five-point Likert Scale and open-ended prompts will be used to assess acceptability (see appendix) upon completion of the 20-week intervention
Feasibility of Program: Retention Rate	From enrollment to 20 weeks	Percentage of enrolled participants who complete the 20-week intervention. Unit of Measure: Percentage (%) of participants who complete the program
Feasibility of Program: Session Attendance	Over the 20-week intervention period	Number of nutrition and wellness group sessions attended per participant. Unit of Measure: Count (number of sessions attended)
Feasibility of Program: Adherence to Exercise Plan - Resistance Training	Over the 20-week intervention period	Percentage of prescribed resistance training sessions (2x/week) completed by each participant.; Unit of Measure: Percentage (%) completion rate
Feasibility of Program: Adherence to Exercise Plan - Walking Goals	Over the 20-week intervention period	Percentage of weekly walking goals met by each participant. Unit of Measure: Percentage (%) completed goals
Feasibility of Program: Data Completeness	From baseline to 20-week follow-up	Percentage of participants with complete data at baseline, end of treatment, and 20-week follow-up.; Unit of Measure: Percentage (%) complete data
Feasibility of Program: Protocol Fidelity	Over the 20-week intervention period	Percentage of intervention components delivered as intended, per protocol. Unit of Measure: Percentage (%) delivered
Feasibility of Program: Adverse Events	Over the 20-week intervention period	Number of safety issues reported by staff or participants during the intervention.; Unit of Measure: Count (number of adverse events)

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes of Interest: Quality of Life	From enrollment to the end of the intervention at 20 weeks	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.
Clinical Outcomes of Interest: Change in Sarcopenia Risk	From baseline to week 20	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.
Clinical Outcomes of Interest: Change in Depression Symptoms	From baseline to week 20	Assessed using the Patient Health Questionnaire-9 (PHQ-9) at baseline and week 20.; Unit of Measure: Units on a scale (0-27) Interpretation: Higher scores indicate more severe depressive symptoms.
Clinical Outcomes of Interest: Change in Anxiety Symptoms	From baseline to week 20	Assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7) at baseline and week 20.; Unit of Measure: Units on a scale (0-21) Interpretation: Higher scores indicate more severe anxiety symptoms.
Clinical Outcomes of Interest: Change in Lean Body Mass	From baseline to week 20	Measured via bioimpedance scale at baseline, week 7, and week 20. Unit of Measure: Kilograms (kg)
Clinical Outcomes of Interest: Change in Body Weight	From baseline to week 20	Measured at baseline, bi-weekly, and week 20. Unit of Measure: Kilograms (kg)
Clinical Outcomes of Interest: Change in Grip Strength	From baseline to week 20	Measured using a hand dynamometer at baseline, week 7, and week 20. Unit of Measure: Kilograms (kg)
Clinical Outcomes of Interest: Change in Functional Capacity (6MWT)	From baseline to week 20	Measured using the 6-minute walk test at baseline, week 7, and week 20. Unit of Measure: Meters walked

Trial Locations

Locations (2)

Renown Regional Medical Center; 🇺🇸 Reno, Nevada, United States

Conrad Breast Center at South Meadows; 🇺🇸 Reno, Nevada, United States