Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07160296

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Conrad Breast Center at South Meadows, Reno, Nevada, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

20-Week Lifestyle Program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. 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)

  7. 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)

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kristen Gurnea, MPH

CONTACT

[email protected]

17759823646

Sponsors and collaborators

Lead sponsor

Renown Health

Other

Registry information

Acronym: STRONGER

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.