Pre-treatment nutrition and exercise program for head and neck cancer patients

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

This program will try nutrition counseling and an exercise program for people with head and neck cancer who are about to start radiation or chemoradiation to see if it is workable and acceptable.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Miami (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT07318220 on ClinicalTrials.gov

What this trial studies

The protocol offers referral to oncology nutritional counseling and a structured exercise program delivered before and during radiotherapy or chemoradiation for non-metastatic head and neck squamous cell carcinoma. The study aims to identify barriers, supports, and patient preferences for prehabilitation while implementing a standardized prescription at the Sylvester Comprehensive Cancer Center. Eligible adults (18–80) planned for curative RT/CRT and cleared for exercise, who speak English or Spanish, are enrolled and followed for feasibility and acceptability outcomes. Patients with metastatic disease or contraindications to diet change or exercise are excluded.

Who should consider this trial

Good fit: Adults 18–80 with non-metastatic squamous cell carcinoma of the head and neck who are planned for curative radiotherapy or chemoradiation at the University of Miami, cleared for exercise, and who speak English or Spanish are ideal candidates.

Not a fit: Patients with metastatic cancer, those with medical contraindications to dietary change or exercise, those who cannot start prehabilitation before radiation begins, or who cannot attend the program are unlikely to benefit.

Why it matters

Potential benefit: If successful, the program could help patients maintain nutrition and physical function during treatment and reduce treatment-related complications.

How similar studies have performed: Prehabilitation combining nutrition and exercise has shown promising results in surgical oncology and in some small head and neck cancer pilots, but large definitive trials are limited.

Eligibility 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.

Where this trial is running

Miami, Florida

• University of Miami — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Akina Natori, MD, MSPH — University of Miami
• Study coordinator: Akina Natori, MD, MSPH

Conditions Head and Neck Cancer