Prehabilitation Protocol for Head and Neck Cancer Patients

NCT ID: NCT07318220

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-30
• Study Completion Date: 2027-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Referral to Oncology Nutritional Counseling and Exercise Program

Intervention Type: 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.

Interventions

Referral to Oncology Nutritional Counseling and Exercise Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Akina Natori

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akina Natori, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Akina Natori, MD, MSPH

Role: CONTACT

akn571@miami.edu

(305) 243-6005

Facility Contacts

Akina Natori, MD, MSPH

Role: primary

akn571@miami.edu

305-243-6005

Other Identifiers

20230516

Identifier Type: -

Identifier Source: org_study_id