Recruiting

Prehabilitation

Sponsor:

University of Miami

Code:

NCT07318220

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Referral to Oncology Nutritional Counseling and Exercise Program

Study Details

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 ID

NCT07318220

Start date

May 1, 2026

Status verified date

Aug, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 squamous cell carcinoma originating in the head and neck (oral cavity, oropharynx, hypopharynx, larynx, and nasopharynx).
3. Stage I-III or de novo Stage IV
4. Patients with a plan for radiation therapy (RT) / chemoradiation therapy (CRT) at SCCC\* - \*Patients who underwent surgery for the HNC are still eligible.
5. If this is a second primary squamous cell carcinoma originating in the head and neck, a patient is eligible if the last RT or CRT was completed more than 6 months ago.
6. Clearance for exercise by the medical team.
7. Patients who do not have their first treatment scheduled within 7 days at the time of recruitment.
8. An English or Spanish speaker.

Aim 2 Exclusion Criteria:

1. A patient who cannot complete the baseline assessment and/or start prehabilitation by the initiation of RT/CRT.
2. Any contraindication for diet change or exercising as determined by a physician.
3. A patient who is not an English or Spanish speaker.
4. History of dementia or major psychiatric disease which would interfere with study.
5. History of recent (≤1 yr) stroke, myocardial infarction, or congestive heart failure
6. Eastern Cooperative Oncology Group (ECOG) equal to or higher than 2.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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.

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.

Primary outcome measure

  • Aim 2: Feasibility of Participant Engagement in Prehabilitation Prescription Program [ Time Frame: Up to 18 Weeks ]
  • Aim 2: Feasibility of Participant Attendance to Scheduled Visits of the Prehabilitation Prescription Protocol [ Time Frame: Up to 18 Weeks ]
  • Aim 2: Acceptability of Participants That Feel Satisfied with the Prehabilitation Prescription Protocol [ Time Frame: Up to 18 Weeks ]

Central Contacts and Locations

Central contacts

Akina Natori, MD, MSPH

(305) 243-6005akn571@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Akina Natori, MD, MSPH

(305) 243-6005akn571@miami.edu

Principal Investigator:

Akina Natori, MD, MSPH

More Information

Sponsor

University of Miami

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-09-01.