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

NCT07160296 | Recruiting

• 1 other identifier: 1002504325
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

ChemoRT; HNC; Wellness

Outcome Measures

Primary Outcomes (9)

• Feasibility of Program: Recruitment Rate

  Percentage of eligible patients who enroll in the study. Unit of Measure: Percentage (%) enrolled compared to not enrolled of eligible participants approached.

  From enrollment to the end of the intervention at 20 weeks

• Program Acceptability

  A five-point Likert Scale and open-ended prompts will be used to assess acceptability (see appendix) upon completion of the 20-week intervention

  From enrollment to the end of the intervention at 20 weeks

• Feasibility of Program: Retention Rate

  Percentage of enrolled participants who complete the 20-week intervention. Unit of Measure: Percentage (%) of participants who complete the program

  From enrollment to 20 weeks

• Feasibility of Program: Session Attendance

  Number of nutrition and wellness group sessions attended per participant. Unit of Measure: Count (number of sessions attended)

  Over the 20-week intervention period

• Feasibility of Program: Adherence to Exercise Plan - Resistance Training

  Percentage of prescribed resistance training sessions (2x/week) completed by each participant. Unit of Measure: Percentage (%) completion rate

  Over the 20-week intervention period

• Feasibility of Program: Adherence to Exercise Plan - Walking Goals

  Percentage of weekly walking goals met by each participant. Unit of Measure: Percentage (%) completed goals

  Over the 20-week intervention period

• Feasibility of Program: Data Completeness

  Percentage of participants with complete data at baseline, end of treatment, and 20-week follow-up. Unit of Measure: Percentage (%) complete data

  From baseline to 20-week follow-up

• Feasibility of Program: Protocol Fidelity

  Percentage of intervention components delivered as intended, per protocol. Unit of Measure: Percentage (%) delivered

  Over the 20-week intervention period

• Feasibility of Program: Adverse Events

  Number of safety issues reported by staff or participants during the intervention. Unit of Measure: Count (number of adverse events)

  Over the 20-week intervention period

Secondary Outcomes (8)

• Clinical Outcomes of Interest: Quality of Life

  From enrollment to the end of the intervention at 20 weeks

• Clinical Outcomes of Interest: Change in Sarcopenia Risk

  From baseline to week 20

• Clinical Outcomes of Interest: Change in Depression Symptoms

  From baseline to week 20

• Clinical Outcomes of Interest: Change in Anxiety Symptoms

  From baseline to week 20

• Clinical Outcomes of Interest: Change in Lean Body Mass

  From baseline to week 20

Study Arms (1)

Open Label Arm

EXPERIMENTAL

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.

Behavioral: 20-Week Lifestyle Program

Interventions

20-Week Lifestyle Program 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.

Open Label Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe malnutrition requiring exclusive enteral feeding at baseline
• Comorbidities that preclude safe participation in exercise
• Cognitive or psychiatric conditions that impair study engagement

Sponsors & Collaborators

• Renown Health: lead

Study Sites (2)

Renown Regional Medical Center

Reno, Nevada, 89502, United States

RECRUITING

Conrad Breast Center at South Meadows

Reno, Nevada, 89521, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Kristen Gurnea, MPH

CONTACT

17759823646; Renown-CRD@renown.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 8, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

US (2)