Exercise to enhance response to immunotherapy in skin cancer patients
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
This study tests if exercising on the day of treatment can help skin cancer patients respond better to their immunotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AdventHealth Translational Research Institute Academic / other |
| Drugs / interventions | avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab, immunotherapy |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT06008977 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the feasibility of implementing an exercise intervention for patients with cutaneous cancers, such as melanoma and squamous cell carcinoma, who are scheduled to receive checkpoint blockade immunotherapy. Participants will engage in a day-of-therapy exercise regimen to evaluate its impact on treatment response. The study will gather preliminary data on how exercise may influence the effectiveness of immunotherapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with cutaneous melanoma, squamous cell carcinoma, or Merkel cell carcinoma who are about to start checkpoint blockade immunotherapy.
Not a fit: Patients who are unable to perform moderate exercise or those receiving other therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the effectiveness of immunotherapy for patients with cutaneous cancers.
How similar studies have performed: While this approach is novel, similar studies exploring the impact of exercise on cancer treatment outcomes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and females ≥18 years of age. 2. Able to read and speak English fluently. 3. Reported ability to complete 20-30 minutes moderate exercise per positive response to, "Can you currently walk unaided for six minutes or more?" 4. Scheduled for first-time checkpoint blockade immunotherapy with avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab in the absence of other therapies (e.g. targeted therapy) with the following diagnosis: 1. Adjuvant setting: cutaneous melanoma. 2. Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma. 5. States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study. 6. Voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study. Exclusion Criteria: 7. Presence of medical conditions, such as severe cardiovascular disease for which exercise may be contraindicated. Participants may be referred to their medical team to obtain a cardiology approval. 8. Presence of major postoperative complications for which an exercise intervention may be contraindicated. 9. Currently has a chronic, contagious, infectious disease, such as active tuberculosis, active Hepatitis B or C, HIV, or COVID-19, per self-report. 10. Currently pregnant, lactating or planning to become pregnant (positive result on urine pregnancy testing). 11. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.
Where this trial is running
Orlando, Florida
- AdventHealth Translational Research Institute — Orlando, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Bret Goodpaster, PhD — Study Principal Investigator
- Study coordinator: Recruitment Department
- Email: Fh.tri.recruitment@adventhealth.com
- Phone: 407-303-7100
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.