Supporting Treatment Resilience With Optimized Nutrition and Guided Exercise in Head and Neck Cancer Patients Undergoing Chemoradiation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 20-Week Lifestyle Program.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Behavioral 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 Ca
Primary outcome measures
- Feasibility of Program: Recruitment Rate [Time frame: From enrollment to the end of the intervention at 20 weeks]
- Program Acceptability [Time frame: From enrollment to the end of the intervention at 20 weeks]
- Feasibility of Program: Retention Rate [Time frame: From enrollment to 20 weeks]
- Feasibility of Program: Session Attendance [Time frame: Over the 20-week intervention period]
- Feasibility of Program: Adherence to Exercise Plan - Resistance Training [Time frame: Over the 20-week intervention period]
- Feasibility of Program: Adherence to Exercise Plan - Walking Goals [Time frame: Over the 20-week intervention period]
- Feasibility of Program: Data Completeness [Time frame: From baseline to 20-week follow-up]
- Feasibility of Program: Protocol Fidelity [Time frame: Over the 20-week intervention period]
- Feasibility of Program: Adverse Events [Time frame: Over the 20-week intervention period]
Secondary outcome measures (8)
- Clinical Outcomes of Interest: Quality of Life [Time frame: From enrollment to the end of the intervention at 20 weeks]
- Clinical Outcomes of Interest: Change in Sarcopenia Risk [Time frame: From baseline to week 20]
- Clinical Outcomes of Interest: Change in Depression Symptoms [Time frame: From baseline to week 20]
- Clinical Outcomes of Interest: Change in Anxiety Symptoms [Time frame: From baseline to week 20]
- Clinical Outcomes of Interest: Change in Lean Body Mass [Time frame: From baseline to week 20]
- Clinical Outcomes of Interest: Change in Body Weight [Time frame: From baseline to week 20]
- Clinical Outcomes of Interest: Change in Grip Strength [Time frame: From baseline to week 20]
- Clinical Outcomes of Interest: Change in Functional Capacity (6MWT) [Time frame: From baseline to week 20]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Renown Regional Medical Center — Reno
- Conrad Breast Center at South Meadows — Reno
Identifiers
NCT: NCT07160296 · 1002504325