Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
Florida
AdventHealth Translational Research Institute
RECRUITING
Orlando
Contact Information
Primary
Recruitment Department
Fh.tri.recruitment@adventhealth.com
407-303-7100
Time Frame
Start Date: 2024-06-03
Estimated Completion Date: 2025-12
Participants
Target number of participants: 20
Treatments
No_intervention: Standard Group- No Exercise (Adjuvant)
Patients randomized to the standard arm will receive clinical care following AH standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.
Active_comparator: Intervention Group- Moderate Exercise (adjuvant)
Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.
No_intervention: Standard Group- No Exercise (Neoadjuvant)
Patients randomized to the standard arm will receive clinical care following AH (AdventHealth) standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.
Active_comparator: Intervention Group- Moderate Exercise (Neoadjuvant)
Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.
Sponsors
Leads: AdventHealth Translational Research Institute

This content was sourced from clinicaltrials.gov