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

Renown Health

Status: Enrolling

Conditions: Head and Neck Cancer

Treatments: Behavioral: 20-Week Lifestyle Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07160296

1002504325

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Open Label Arm

Experimental group

Description:

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.

Treatment:

Behavioral: 20-Week Lifestyle Program