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Head and Neck CancerSTRONGERNCT07160296

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

A study testing 20-Week Lifestyle Program in people with Head and Neck Cancer, run by Renown Health at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
20-Week Lifestyle Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
15 Sep 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Severe malnutrition requiring exclusive enteral feeding at baseline
  • Comorbidities that preclude safe participation in exercise
  • Cognitive or psychiatric conditions that impair study engagement

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kristen Gurnea, MPH contact

17759823646

Renown-CRD@renown.org

United States2 sites, 2 recruiting

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Kristen Gurnea, MPH, 17759823646, Renown-CRD@renown.org

    Madeline Hardacre, MD

    Recruiting

  • Conrad Breast Center at South Meadows

    Reno, Nevada, 89521

    Kristen Gurnea, MPH, 17759823646, Renown-CRD@renown.org

    Madeline Hardacre, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
20-Week Lifestyle Program
Keywords
ChemoRT, HNC, Wellness
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20-Week Lifestyle ProgramBehavioural

    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.

Study groups in NCT07160296
Study groupRoleWhat they receive
Open Label ArmExperimentalParticipate 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.
Receives: Behavioral: 20-Week Lifestyle Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the end of the intervention at 20 weeks

  2. 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

    Measured: From enrollment to the end of the intervention at 20 weeks

  3. 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

    Measured: From enrollment to 20 weeks

  4. Feasibility of Program: Session Attendance

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

    Measured: Over the 20-week intervention period

  5. 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

    Measured: Over the 20-week intervention period

  6. Feasibility of Program: Adherence to Exercise Plan - Walking Goals

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

    Measured: Over the 20-week intervention period

  7. 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

    Measured: From baseline to 20-week follow-up

  8. Feasibility of Program: Protocol Fidelity

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

    Measured: Over the 20-week intervention period

  9. 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)

    Measured: Over the 20-week intervention period

Secondary outcomes (8)

  1. 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.

    Measured: From enrollment to the end of the intervention at 20 weeks

  2. 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.

    Measured: From baseline to week 20

  3. Clinical Outcomes of Interest: Change in Depression Symptoms

    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.

    Measured: From baseline to week 20

  4. Clinical Outcomes of Interest: Change in Anxiety Symptoms

    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.

    Measured: From baseline to week 20

  5. Clinical Outcomes of Interest: Change in Lean Body Mass

    Measured via bioimpedance scale at baseline, week 7, and week 20. Unit of Measure: Kilograms (kg)

    Measured: From baseline to week 20

  6. Clinical Outcomes of Interest: Change in Body Weight

    Measured at baseline, bi-weekly, and week 20. Unit of Measure: Kilograms (kg)

    Measured: From baseline to week 20

  7. Clinical Outcomes of Interest: Change in Grip Strength

    Measured using a hand dynamometer at baseline, week 7, and week 20. Unit of Measure: Kilograms (kg)

    Measured: From baseline to week 20

  8. Clinical Outcomes of Interest: Change in Functional Capacity (6MWT)

    Measured using the 6-minute walk test at baseline, week 7, and week 20. Unit of Measure: Meters walked

    Measured: From baseline to week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07160296
Sponsor's protocol ID
1002504325
Acronym
STRONGER
Status last verified
Aug 2025
First submitted
14 Aug 2025
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing 20-Week Lifestyle Program in people with Head and Neck Cancer, run by Renown Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristen Gurnea, MPH (17759823646, Renown-CRD@renown.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Program: Recruitment Rate (time frame: From enrollment to the end of the intervention at 20 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07160296.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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