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

This study is testing a 20-week lifestyle program for adults with head and neck cancer who are receiving chemoradiation therapy (chemoRT). The program includes weekly group nutrition counseling with an oncology dietitian and home-based exercise, such as resistance and mobility exercises with online videos, and daily walking. Researchers want to see if this program can help reduce side effects, improve physical function, and enhance quality of life during treatment. The main goals are to find out if the program is practical to offer and if patients will participate and stay in the program. This study is currently unclear on its status and plans to enroll 30 participants.

Study design
This is an interventional study with a planned enrollment of 30 participants. It aims to assess the feasibility and preliminary effects of a multimodal lifestyle intervention.
What's involved
You would participate in a 20-week lifestyle program, including weekly group nutrition counseling and home-based exercise twice a week, plus daily walking with self-tracking.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for feasibility and acceptability are measured from enrollment to the end of the intervention at 20 weeks.

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NCT07160296

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

Recruiting
NAAges 18+InterventionalSupportive care
Renown Health
~30 participants
Updated 2025-09-08 on ClinicalTrials.gov
What's tested:20-Week Lifestyle Program

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Program: Recruitment Rate
Measured over From enrollment to the end of the intervention at 20 weeks
+8 more outcomes measured

Conditions

Head and Neck Cancer

Explore related trials

Malignant Head and Neck Neoplasm

Where it's being run

2 sites across 1 states
Nevada2

Who to contact

Kristen Gurnea, MPH
[email protected]
17759823646
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Feasibility of Program: Recruitment RateFrom 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 AcceptabilityFrom 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 RateFrom 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 AttendanceOver 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 TrainingOver 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 GoalsOver the 20-week intervention period

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

  • Feasibility of Program: Data CompletenessFrom 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 FidelityOver the 20-week intervention period

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

  • Feasibility of Program: Adverse EventsOver 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)