Recruiting

Lifestyle Intervention

Sponsor:

Renown Health

Code:

NCT07160296

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

20-Week Lifestyle Program

Study Details

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

Study ID

NCT07160296

Start date

Sep 15, 2025

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kristen Gurnea, MPH

17759823646Renown-CRD@renown.org

Locations

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Kristen Gurnea, MPH

17759823646Renown-CRD@renown.org

Principal Investigator:

Madeline Hardacre, MD

Conrad Breast Center at South Meadows

Recruiting

Reno, Nevada, United States, 89521

Contacts

Kristen Gurnea, MPH

17759823646Renown-CRD@renown.org

Principal Investigator:

Madeline Hardacre, MD

More Information

Sponsor

Renown Health

Last update posted

Sep 8, 2025

Last verified

Aug, 2025

Keywords

  • ChemoRT
  • HNC
  • Wellness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Renown Health on 2025-09-08.