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

NCT ID: NCT07160296

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

20-Week Lifestyle Program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renown Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renown Regional Medical Center

Reno, Nevada, United States

Site Status RECRUITING

Conrad Breast Center at South Meadows

Reno, Nevada, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristen Gurnea, MPH

Role: CONTACT

17759823646

Facility Contacts

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Kristen Gurnea, MPH

Role: primary

17759823646

Kristen Gurnea, MPH

Role: primary

17759823646

Other Identifiers

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1002504325

Identifier Type: -

Identifier Source: org_study_id

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