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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have major complications after surgery that may prevent me from exercising.

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I do not have any active contagious diseases like TB, Hepatitis B/C, HIV, or COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathological complete response (pCR)

Relapse-free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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.

0 / 3Eligibility criteria met