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NCT07318220 | RECRUITING | Head and Neck Cancer

Prehabilitation Protocol for Head and Neck Cancer Patients
Sponsor:

University of Miami

Information provided by (Responsible Party):

Autumn Natori

Brief Summary:

The purpose of this research is to help researchers understand the barriers, supports, and preferences for prehabilitation. Prehabilitation in this study means head and neck cancer patients will receive nutritional counseling sessions and attend exercise programs before and during radiotherapy/chemoradiotherapy treatment.

Condition or disease

Head and Neck Cancer

Intervention/treatment

Referral to Oncology Nutritional Counseling and Exercise Program

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Optimizing Cancer Support Services Usage in Patients With Head and Neck Cancer During the Prehabilitation Period
Actual Study Start Date : 2026-04-30
Estimated Primary Completion Date : 2027-04-30
Estimated Study Completion Date : 2027-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Aim 2 Inclusion Criteria: Implement prehabilitation prescription protocol and evaluate the feasibility and acceptability of the prehabilitation prescription protocol in a sample of HNC patients.
  • 1. Age 18 to 80 years old
  • 2. Patients with a diagnosis of non-metastatic squamous cell carcinoma originating in the head and neck (oral cavity, oropharynx, hypopharynx, larynx, and nasopharynx).
  • 3. Patients with a plan for curative radiation therapy (RT) / chemoradiation therapy (CRT) at SCCC\* - \*Patients who underwent surgery for the HNC are still eligible.
  • 4. Clearance for exercise by the medical team.
  • 5. Patients who do not have their first treatment scheduled within 3 weeks at the time of recruitment.
  • 6. An English or Spanish speaker.
  • Aim 2 Exclusion Criteria
    • 1. A patient with a metastatic cancer.
    • 2. A patient who cannot complete the baseline assessment and/or start prehabilitation by the initiation of RT/CRT.
    • 3. Any contraindication for diet change or exercising as determined by a physician.
    • 4. Engaging in \>150 minutes of moderate to vigorous physical activity on average per week for the prior month.
    • 5. A patient who is not an English or Spanish speaker.
    • 6. History of dementia or major psychiatric disease which would interfere with study.
    • 7. History of recent (≤1 yr) stroke, myocardial infarction, or congestive heart failure
    • 8. Eastern Cooperative Oncology Group (ECOG) equal to or higher than 2.
    • Prehabilitation Protocol for Head and Neck Cancer Patients

    Location Details

    NCT07318220

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, Florida

    University of Miami

    Miami, florida, United States, 33136