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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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
• Email: akn571@miami.edu
• Phone: (305) 243-6005

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Phenotype-based Pain Guidance for Head and Neck Cancer-Related Pain (pilot)

  This pilot test sees if tailoring pain treatment to a patient’s pain type can reduce head and neck cancer pain in adults who haven’t started cancer treatment yet.

  Recruiting Phase 2 Shaukat Khanum Memorial Cancer Hospital & Research Centre · Lahore, Punjab Province · NCT07919444

• Airway ultrasound in head and neck cancer patients

  This observational study tests whether neck ultrasound measurements of the airway match CT measurements in adults with maxillofacial cancer undergoing surgery with anesthesia.

  Recruiting at 2 sites University Hospital Dubrava · Zagreb, City of Zagreb and 1 other locations · NCT07910149

• Safe use of metformin and naproxen to help prevent cancer in people with Fanconi anemia

  This study tests whether metformin and naproxen can lower the chance of cancer developing in adults with Fanconi anemia.

  Recruiting at 2 sites Phase 1 Rockefeller University · Minneapolis, Minnesota and 1 other locations · NCT07901959

• Iparomlimab and Tuvonralimab With Cetuximab Before Surgery in Resectable Oral Cancer

  In this phase 2 study, patients with locally advanced, resectable oral squamous cell carcinoma will receive a combination of iparomlimab, tuvonralimab, and cetuximab before surgery to see if the treatment is safe and can shrink tumors.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07882888

• SumMET: Targeted radioligand therapy for c-MET–positive solid tumors

  This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.

  Recruiting at 2 sites Phase 1/2 Full-Life Technologies UK Limited · Minneapolis, Minnesota and 1 other locations · NCT07873450

• Using Silverlon for head and neck patients with tracheostomies

  This early-phase study tests whether Silverlon dressings can prevent severe skin reactions under tracheostomy collars in adults with head and neck cancer.

  Recruiting Phase 1 State University of New York - Upstate Medical University · Syracuse, New York · NCT07856732

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.