Prehabilitation Protocol for Head and Neck Cancer Patients

University of Miami

Status: Enrolling

Conditions: Head and Neck Cancer

Treatments: Behavioral: Referral to Oncology Nutritional Counseling and Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07318220

20230516

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Aim 2: Prehabilitation Prescription Protocol Group

Experimental group

Description:

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.

Treatment:

Behavioral: Referral to Oncology Nutritional Counseling and Exercise Program