Prehabilitation program for patients with head and neck cancer
Exercise and Nutritional Prehabilitation for Head and Neck Cancer Patients
This study is testing a prehabilitation program that includes exercise and nutrition support for people with head and neck cancer to see if it helps them feel better before surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Sacramento, California and 1 other locations) |
| Trial ID | NCT06722508 on ClinicalTrials.gov |
What this trial studies
This research evaluates the safety and acceptability of a prehabilitation program designed for patients diagnosed with head and neck cancer prior to surgery. The program includes a two-week home-based exercise regimen and nutritional guidance aimed at improving patient outcomes. Participants will be monitored for feasibility and safety through assessments such as the Timed Up and Go (TUG) and 6 Minute Walk Test (6MWT) before and after surgery. The study aims to enroll 20 subjects by August 2025, with each participant's involvement lasting approximately three months.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a new diagnosis of head and neck cancer.
Not a fit: Patients with prior treatment for head and neck cancer or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance recovery and overall outcomes for patients undergoing surgery for head and neck cancer.
How similar studies have performed: While the approach of prehabilitation is gaining traction, this specific program is novel and has not been extensively tested in this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: New head and neck cancer diagnosis Age \> 18 Exclusion Criteria: 1. Prior treatment for head and neck cancer (surgery and/or radiation) 2. Acute or unstable cardiac conditions (unstable angina or symptomatic severe aortic stenosis) 3. American Society of Anesthesiologists physical status of 4 and 5 4. Disabling orthopedic or neuromuscular disease 5. Cardiac failure (New York Heart Association functional classes III and IV) 6. Severe chronic obstructive pulmonary disease 7. End-stage liver or kidney disease 8. Inability to swallow and/or feeding tube dependence 9. Any other comorbid medical, physical, and/or mental condition that contraindicates exercise or oral nutrition 10. Adults unable to consent 11. Age 17.99 or younger 12. Prisoners, pregnant women, or other vulnerable population
Where this trial is running
Sacramento, California and 1 other locations
- UC Davis Health — Sacramento, California, United States (Recruiting)
- UC Davis Medical Center — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Marianne S Abouyared, MD — University of California, Davis
- Study coordinator: Randev Sandhu CRC Supervisor, BS
- Email: rssandhu@ucdavis.edu
- Phone: 9167342863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.