Exercise and nutrition program for head and neck cancer survivors
The ENHANCE Study: Exercise and Nutrition in Head And Neck CancEr Survivors: A Randomized Clinical Trial
This study tests if a special exercise and Mediterranean diet program can help people who have just been diagnosed with head and neck cancer feel better and recover more effectively during their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT05798780 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and evaluate a physical activity and dietary intervention specifically designed for patients who have been newly diagnosed with head and neck cancers. Participants will engage in either an exercise and nutrition program or a nutrition-only program, focusing on adopting a Mediterranean diet. The study will assess the impact of these interventions on the health and recovery of patients undergoing treatment with radiation or chemoradiation. The goal is to enhance the overall well-being and quality of life for these cancer survivors.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been newly diagnosed with tumors of the oral cavity, oropharynx, hypopharynx, or larynx and are scheduled to receive radiation or chemoradiation.
Not a fit: Patients who are pregnant, have head and neck cancer as a secondary diagnosis, or are scheduled for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the health outcomes and quality of life for head and neck cancer survivors.
How similar studies have performed: While similar interventions focusing on exercise and nutrition have shown promise in other cancer populations, this specific approach for head and neck cancer survivors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 years old * Newly diagnosed tumors of the oral cavity, oropharynx, hypopharynx, or larynx * No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis) * Able to speak and read English * Able to consume food orally * Willing to consume an alternative Mediterranean diet * Scheduled to receive treatment with radiation or chemoradiation * Screened via the Physical Activity Readiness Questionnaire (PAR-Q+) with medical clearance of treating physicians, as necessary * Able to provide informed consent Exclusion Criteria: * Women who are pregnant * Head and Neck Cancer not the primary diagnosis * Patients scheduled to receive surgery * Patients on enteral or parental nutrition
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Sylvia Crowder, PhD — Moffitt Cancer Center
- Study coordinator: Sylvia Crowder, PhD
- Email: Sylvia.Crowder@moffitt.org
- Phone: 813-745-6849
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.