Prehabilitation Protocol for Head and Neck Cancer Patients

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07318220
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Referral to Oncology Nutritional Counseling and Exercise Program — BEHAVIORAL
    Participants will be referred by their healthcare provider to an oncology nutritional counseling and exercise program administered standard of care by the Cancer Support Service at the Sylvester Comprehensive Cancer Center. Participants will be scheduled to the predetermined frequency and length of visits with oncology dietitians and exercise physiologists per the prehabilitation prescription protocol developed during the pre-implementation period.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Dec 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Aim 2: Prehabilitation Prescription Protocol Group
    Participants in this group will be referred to a prehabilitation prescription protocol of nutritional counseling and exercise for HNC patients. Participants will attend for nutritional counseling and exercise sessions for the duration of their radiation therapy (RT) or chemoradiation therapy (CRT) for HNC. The duration of these sessions depends on the participant's treatment plan and the timing of enrollment. Participants will also have three in-person assessments during the study period during the following timepoints (T), to assess feasibility and acceptability of the prehabilitation prescription protocol: Baseline (T1), at the completion of RT/CRT (T2), and 8 weeks after the completion of RT/CRT and the exit survey (T3). Total participation duration is up to 18 weeks.

Primary Outcome Measure

Aim 2: Feasibility of Participant Engagement in Prehabilitation Prescription Program [ Time Frame: Up to 18 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Akina Natori, MD, MSPH
[email protected]
305-243-6005
Akina Natori, MD, MSPH (PRINCIPAL_INVESTIGATOR)
Tracy E Crane, PhD, RDN (PRINCIPAL_INVESTIGATOR)
Frank Penedo, PhD (PRINCIPAL_INVESTIGATOR)
Melissa Pentecost-Lopez, PhD, MS, RDN (PRINCIPAL_INVESTIGATOR)
Erin R Kaye, MD (PRINCIPAL_INVESTIGATOR)
Stuart Samuels, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Miami· Miami, FL

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