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Exercise for Cancer Immunotherapy Response (EX-BOOST Trial)
N/A
Recruiting
Led By Bret Goodpaster, PhD
Research Sponsored by AdventHealth Translational Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
EX-BOOST Trial Summary
This trial will explore the feasibility & impact of exercise on cancer patients before immunotherapy to improve outcomes.
Who is the study for?
This trial is for adults over 18 who speak English and are about to start checkpoint blockade immunotherapy for the first time, targeting skin cancers like melanoma. They must be able to do moderate exercise, follow the study protocol, and not have severe health issues that make exercise unsafe.Check my eligibility
What is being tested?
The study tests if exercising on the day you get immunotherapy (with drugs like avelumab or pembrolizumab) is feasible and affects treatment outcomes in patients with certain skin cancers.See study design
What are the potential side effects?
Since this trial focuses on exercise during immunotherapy treatment, side effects may include typical reactions to physical activity such as muscle soreness or fatigue but will vary based on individual health conditions.
EX-BOOST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am about to start my first immunotherapy for skin cancer without other treatments.
EX-BOOST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological complete response (pCR)
Relapse-free survival
EX-BOOST Trial Design
4Treatment groups
Active Control
Group I: Intervention Group- Moderate Exercise (adjuvant)Active Control1 Intervention
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.
Group II: Intervention Group- Moderate Exercise (Neoadjuvant)Active Control1 Intervention
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.
Group III: Standard Group- No Exercise (Neoadjuvant)Active Control1 Intervention
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.
Group IV: Standard Group- No Exercise (Adjuvant)Active Control1 Intervention
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.
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Who is running the clinical trial?
AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
20,161 Total Patients Enrolled
Bret Goodpaster, PhDPrincipal InvestigatorStudy Principal Investigator
5 Previous Clinical Trials
460 Total Patients Enrolled
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