NCT07160296 · Renown Health
Supporting Treatment Resilience With Optimized Nutrition and Guided Exercise in Head and Neck Cancer Patients Undergoing Chemoradiation
(STRONGER)
What this study is 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).
View original scientific description
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.
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 Cancer training series led by a speech pathologist.
Primary outcome measures
Feasibility of Program: Recruitment Rate
Time frame: From enrollment to the end of the intervention at 20 weeks
Percentage of eligible patients who enroll in the study. Unit of Measure: Percentage (%) enrolled compared to not enrolled of eligible participants approached.
Program Acceptability
Time frame: From enrollment to the end of the intervention at 20 weeks
A five-point Likert Scale and open-ended prompts will be used to assess acceptability (see appendix) upon completion of the 20-week intervention
Feasibility of Program: Retention Rate
Time frame: From enrollment to 20 weeks
Percentage of enrolled participants who complete the 20-week intervention. Unit of Measure: Percentage (%) of participants who complete the program
Feasibility of Program: Session Attendance
Time frame: Over the 20-week intervention period
Number of nutrition and wellness group sessions attended per participant. Unit of Measure: Count (number of sessions attended)
Feasibility of Program: Adherence to Exercise Plan - Resistance Training
Time frame: Over the 20-week intervention period
Percentage of prescribed resistance training sessions (2x/week) completed by each participant. Unit of Measure: Percentage (%) completion rate
Feasibility of Program: Adherence to Exercise Plan - Walking Goals
Time frame: Over the 20-week intervention period
Percentage of weekly walking goals met by each participant. Unit of Measure: Percentage (%) completed goals
Feasibility of Program: Data Completeness
Time frame: From baseline to 20-week follow-up
Percentage of participants with complete data at baseline, end of treatment, and 20-week follow-up. Unit of Measure: Percentage (%) complete data
Feasibility of Program: Protocol Fidelity
Time frame: Over the 20-week intervention period
Percentage of intervention components delivered as intended, per protocol. Unit of Measure: Percentage (%) delivered
Feasibility of Program: Adverse Events
Time frame: Over the 20-week intervention period
Number of safety issues reported by staff or participants during the intervention. Unit of Measure: Count (number of adverse events)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Reno, Nevada
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 8, 2025 · Source of record for eligibility and locations