NCT07318220 · University of Miami
Prehabilitation Protocol for Head and Neck Cancer Patients
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Implement prehabilitation prescription protocol and evaluate the feasibility and acceptability of the prehabilitation prescription protocol in a sample of HNC patients.
- Age 18 to 80 years old
- Patients with a diagnosis of non-metastatic squamous cell carcinoma originating in the head and neck (oral cavity, oropharynx, hypopharynx, larynx, and nasopharynx).
- Patients with a plan for curative radiation therapy (RT) / chemoradiation therapy (CRT) at SCCC\
- - \*Patients who underwent surgery for the HNC are still eligible.
- Clearance for exercise by the medical team.
- Patients who do not have their first treatment scheduled within 3 weeks at the time of recruitment.
- An English or Spanish speaker. Aim 2
Exclusion criteria
- A patient with a metastatic cancer.
- A patient who cannot complete the baseline assessment and/or start prehabilitation by the initiation of RT/CRT.
- Any contraindication for diet change or exercising as determined by a physician. week for the prior month.
- A patient who is not an English or Spanish speaker.
- History of dementia or major psychiatric disease which would interfere with study.
- History of recent (≤1 yr) stroke, myocardial infarction, or congestive heart failure
- Eastern Cooperative Oncology Group (ECOG) equal to or higher than 2.
Where
- Miami, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations