Prehabilitation Protocol for Head and Neck Cancer Patients

NCT07318220 | Recruiting

• 1 other identifier: 20230516
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (3)

• Aim 2: Feasibility of Participant Engagement in Prehabilitation Prescription Program

  Feasibility will be measured as the percentage of participants that agree to participate in the prehabilitation prescription protocol. Criterion for success: At least (≥) 50% of all eligible participants agree to participate in the prehabilitation prescription protocol.

  Up to 18 Weeks

• Aim 2: Feasibility of Participant Attendance to Scheduled Visits of the Prehabilitation Prescription Protocol

  Feasibility will be measured as the percentage of participants attending scheduled visits of the prehabilitation prescription protocol. Criterion for success: At least (≥) 70% of participants attend all scheduled visits.

  Up to 18 Weeks

• Aim 2: Acceptability of Participants That Feel Satisfied with the Prehabilitation Prescription Protocol

  Acceptability will be measured as the percentage of participants that report satisfaction with the prehabilitation prescription protocol. Criterion for success: At least (≥) 80% of participants complete the prehabilitation prescription protocol.

  Up to 18 Weeks

Study Arms (1)

Aim 2: Prehabilitation Prescription Protocol Group

EXPERIMENTAL

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.

Behavioral: Referral to Oncology Nutritional Counseling and Exercise Program

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.

Aim 2: Prehabilitation Prescription Protocol Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years old
• Patients with a diagnosis of non-metastatic squamous cell carcinoma originating in the head and neck (oral cavity, oropharynx, hypopharynx, larynx, and nasopharynx).
• Patients with a plan for curative radiation therapy (RT) / chemoradiation therapy (CRT) at SCCC\* - \*Patients who underwent surgery for the HNC are still eligible.
• Clearance for exercise by the medical team.
• Patients who do not have their first treatment scheduled within 3 weeks at the time of recruitment.
• An English or Spanish speaker.

You may not qualify if:

• A patient with a metastatic cancer.
• A patient who cannot complete the baseline assessment and/or start prehabilitation by the initiation of RT/CRT.
• Any contraindication for diet change or exercising as determined by a physician.
• Engaging in \>150 minutes of moderate to vigorous physical activity on average per week for the prior month.
• A patient who is not an English or Spanish speaker.
• History of dementia or major psychiatric disease which would interfere with study.
• History of recent (≤1 yr) stroke, myocardial infarction, or congestive heart failure
• Eastern Cooperative Oncology Group (ECOG) equal to or higher than 2.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Akina Natori, MD, MSPH

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akina Natori, MD, MSPH

CONTACT

(305) 243-6005; akn571@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 5, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (1)