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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 below
Select...
I am about to start my first immunotherapy for skin cancer without other treatments.

EX-BOOST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

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.

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open recruitment slots for this investigation?

"According to clinicaltrials.gov, this medical trial is not currently accepting new enrollees. The study was initially posted on September 1st 2023 and the most recent update was released on the 11th of that same month. Although it's no longer open for recruitment, there are still 2593 other studies recruiting participants as we speak."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
2023. "Exercise to Boost Response to Checkpoint Blockade Immunotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008977.
All > Merkel Cell Carcinoma
~13 spots leftby May 2025
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