RecruitingNot ApplicableNCT06008977

Exercise to Boost Response to Checkpoint Blockade Immunotherapy


Sponsor

AdventHealth Translational Research Institute

Enrollment

20 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

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 carcinoma (cuSCC), and Merkel cell carcinoma, scheduled to receive checkpoint blockade immunotherapy, and ii) preliminary data on the impact of a day-of-therapy exercise intervention.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a structured exercise program can boost the effectiveness of immunotherapy (specifically checkpoint blockade drugs) in cancer patients. Participants will be randomly assigned to an exercise group or a standard care group while receiving their scheduled immunotherapy. **You may be eligible if...** - You are 18 or older - You can read and speak English - You are able to walk unaided for at least 6 minutes - You are scheduled to start immunotherapy (avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab) for melanoma, squamous cell skin cancer, or Merkel cell carcinoma - You are willing to follow the prescribed exercise plan and complete study forms **You may NOT be eligible if...** - You have a serious heart condition that makes exercise unsafe - You have major complications from recent surgery - You have an active contagious disease such as tuberculosis, active hepatitis B or C, HIV, or COVID-19 - You are receiving other cancer treatments alongside immunotherapy (e.g., targeted therapy) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

OTHERExercise Test

Supervised pedaling on an ergometer (stationary bike) at a moderate pace for a goal of 30 minutes. The exercise test will be scheduled at infusion visits 1, 6, and 12 or 1 and 3 over the treatment cycle, depending on the group assignment.


Locations(1)

AdventHealth Translational Research Institute

Orlando, Florida, United States

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NCT06008977


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