Status:
RECRUITING
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
Lead Sponsor:
AdventHealth Translational Research Institute
Conditions:
Cutaneous Melanoma
Cutaneous Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this pilot study will be to provide i) information on feasibility implementing an exercise intervention trial among patients with cutaneous cancers, including melanoma, squamous cell ca...
Eligibility Criteria
Inclusion
- Males and females ≥18 years of age.
- Able to read and speak English fluently.
- Reported ability to complete 20-30 minutes moderate exercise per positive response to, "Can you currently walk unaided for six minutes or more?"
- 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:
- Adjuvant setting: cutaneous melanoma.
- Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma.
- States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study.
- 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
- 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.
- Presence of major postoperative complications for which an exercise intervention may be contraindicated.
- Currently has a chronic, contagious, infectious disease, such as active tuberculosis, active Hepatitis B or C, HIV, or COVID-19, per self-report.
- Currently pregnant, lactating or planning to become pregnant (positive result on urine pregnancy testing).
- 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.
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06008977
Start Date
June 3 2024
End Date
December 1 2025
Last Update
June 4 2025
Active Locations (1)
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1
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32804