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Clinical Trial 22330

Cancer Type: Head & Neck
Study Type: Supportive Care
NCT#: NCT05798780

Phase: N/A
Principal Investigator: Crowder, Sylvia

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors: A Randomized Clinical Trial

Summary

The purpose of the study is to design a physical activity and dietary intervention for head and neck cancer patients.

Objective

Aim 1: Establish feasibility/acceptability of the ENHANCE- Exercise and Nutrition in Head And Neck CancEr intervention via a pilot RCT in HNC patients. Approach: Recruit n=40 HNC patients (n=20 ENHANCE, n=20 Control Group Usual Care+Fitbit). Goal: Evaluate a set of feasibility and acceptability benchmarks including: a) Feasibility: rates of recruitment b) Adherence: session completion rate and behavior change. c) Acceptability: participant ratings of satisfaction with the intervention d) Sensitivity assessment (exploratory): BIA measures, QOL, FitBit, and diet at baseline (pre-treatment) and 12-week (post-treatment) follow-up to inform the future R01. Aim 2: Further revise and refine the ENHANCE intervention. Approach: Based on data and survey responses in Aim 1, we will further refine and revise the intervention to best meet the unique needs of HNC patients.

Treatments

Therapies

Medications

Inclusion Criteria

  • >18 years old
  • Newly diagnosed tumors of the oral cavity, oropharynx, hypopharynx, or larynx
  • No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
  • Able to speak and read English
  • Able to consume food orally
  • Willing to consume an alternative Mediterranean diet
  • Scheduled to receive treatment with radiation or chemoradiation
  • Screened via the Physical Activity Readiness Questionnaire (PAR-Q+) with medical clearance of treating physicians, as necessary
  • Able to provide informed consent

    • Exclusion Criteria

  • Women who are pregnant
  • Head and Neck Cancer not the primary diagnosis
  • Patients scheduled to receive surgery
  • Patients on enteral or parental nutrition

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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