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

August 29, 2025 updated by: Renown Health

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Madeline Hardacre, MD
      • Reno, Nevada, United States, 89521
        • Recruiting
        • Conrad Breast Center at South Meadows
        • Contact:
        • Principal Investigator:
          • Madeline Hardacre, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label Arm

Participate in a 20-week lifestyle program that includes:

  • 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.
Behavioral: 20-Week Lifestyle Program

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Program: Recruitment Rate
Time Frame: 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.
From enrollment to the end of the intervention at 20 weeks
Program Acceptability
Time Frame: 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
From enrollment to the end of the intervention at 20 weeks
Feasibility of Program: Retention Rate
Time Frame: 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
From enrollment to 20 weeks
Feasibility of Program: Session Attendance
Time Frame: Over the 20-week intervention period
Number of nutrition and wellness group sessions attended per participant. Unit of Measure: Count (number of sessions attended)
Over the 20-week intervention period
Feasibility of Program: Adherence to Exercise Plan - Resistance Training
Time Frame: Over the 20-week intervention period

Percentage of prescribed resistance training sessions (2x/week) completed by each participant.

Unit of Measure: Percentage (%) completion rate
Over the 20-week intervention period
Feasibility of Program: Adherence to Exercise Plan - Walking Goals
Time Frame: Over the 20-week intervention period
Percentage of weekly walking goals met by each participant. Unit of Measure: Percentage (%) completed goals
Over the 20-week intervention period
Feasibility of Program: Data Completeness
Time Frame: 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
From baseline to 20-week follow-up
Feasibility of Program: Protocol Fidelity
Time Frame: Over the 20-week intervention period
Percentage of intervention components delivered as intended, per protocol. Unit of Measure: Percentage (%) delivered
Over the 20-week intervention period
Feasibility of Program: Adverse Events
Time Frame: 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)
Over the 20-week intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcomes of Interest: Quality of Life
Time Frame: 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.
From enrollment to the end of the intervention at 20 weeks
Clinical Outcomes of Interest: Change in Sarcopenia Risk
Time Frame: 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.
From baseline to week 20
Clinical Outcomes of Interest: Change in Depression Symptoms
Time Frame: 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.
From baseline to week 20
Clinical Outcomes of Interest: Change in Anxiety Symptoms
Time Frame: 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.
From baseline to week 20
Clinical Outcomes of Interest: Change in Lean Body Mass
Time Frame: From baseline to week 20
Measured via bioimpedance scale at baseline, week 7, and week 20. Unit of Measure: Kilograms (kg)
From baseline to week 20
Clinical Outcomes of Interest: Change in Body Weight
Time Frame: From baseline to week 20
Measured at baseline, bi-weekly, and week 20. Unit of Measure: Kilograms (kg)
From baseline to week 20
Clinical Outcomes of Interest: Change in Grip Strength
Time Frame: From baseline to week 20
Measured using a hand dynamometer at baseline, week 7, and week 20. Unit of Measure: Kilograms (kg)
From baseline to week 20
Clinical Outcomes of Interest: Change in Functional Capacity (6MWT)
Time Frame: From baseline to week 20
Measured using the 6-minute walk test at baseline, week 7, and week 20. Unit of Measure: Meters walked
From baseline to week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renown Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 14, 2025

First Submitted That Met QC Criteria

August 29, 2025

First Posted (Estimated)

September 8, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1002504325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

Clinical Trials on 20-Week Lifestyle Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe