Prehabilitation Protocol for Head and Neck Cancer Patients

Optimizing Cancer Support Services Usage in Patients With Head and Neck Cancer During the Prehabilitation Period

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: Referral to Oncology Nutritional Counseling and Exercise Program

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Akina Natori, MD, MSPH; Phone Number: (305) 243-6005; Email: akn571@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Frank Penedo, PhD
      • Principal Investigator: Stuart Samuels, MD, PhD
      • Principal Investigator: Tracy E Crane, PhD, RDN
      • Contact: Akina Natori, MD, MSPH; Phone Number: 305-243-6005; Email: akn571@miami.edu
      • Principal Investigator: Akina Natori, MD, MSPH
      • Principal Investigator: Melissa Pentecost-Lopez, PhD, MS, RDN
      • Principal Investigator: Erin R Kaye, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Akina Natori, MD, MSPH, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 20230516

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No