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
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-09-15
2026-12-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Comorbidities that preclude safe participation in exercise
* Cognitive or psychiatric conditions that impair study engagement
18 Years
ALL
No
Sponsors
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Renown Health
OTHER
Responsible Party
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Locations
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Renown Regional Medical Center
Reno, Nevada, United States
Conrad Breast Center at South Meadows
Reno, Nevada, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1002504325
Identifier Type: -
Identifier Source: org_study_id
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