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Trial Title:
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
NCT ID:
NCT06008977
Condition:
Cutaneous Melanoma
Cutaneous Squamous Cell Carcinoma
Merkel Cell Carcinoma
Conditions: Official terms:
Carcinoma, Merkel Cell
Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
We will use stratified block randomization to assure non-biased assignment to the
exercise intervention arm. Within each treatment setting, adjuvant and neoadjuvant, 10
patients will be randomized to the exercise intervention arm and 10 to the standard
treatment arm. Within the neoadjuvant setting, randomization also will be blocked within
disease type.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Exercise Test
Description:
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.
Arm group label:
Intervention Group- Moderate Exercise (Neoadjuvant)
Arm group label:
Intervention Group- Moderate Exercise (adjuvant)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Males and females ≥18 years of age.
2. Able to read and speak English fluently.
3. Reported ability to complete 20-30 minutes moderate exercise per positive response
to, "Can you currently walk unaided for six minutes or more?"
4. 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:
1. Adjuvant setting: cutaneous melanoma.
2. Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma.
5. States willingness to follow protocol as described, including the prescribed
exercise level and completing any forms needed throughout the study.
6. 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.
Exclusion Criteria:
7. Presence of medical conditions, such as severe cardiovascular disease for which
exercise may be contraindicated. Participants may be referred to their medical team
to obtain a cardiology approval.
8. Presence of major postoperative complications for which an exercise intervention may
be contraindicated.
9. Currently has a chronic, contagious, infectious disease, such as active
tuberculosis, active Hepatitis B or C, HIV, or COVID-19, per self-report.
10. Currently pregnant, lactating or planning to become pregnant (positive result on
urine pregnancy testing).
11. Presence of any condition that, in the opinion of the Investigator, compromises
participant safety or data integrity or the participant's ability to complete the
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AdventHealth Translational Research Institute
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Recruitment Department
Phone:
407-303-7100
Email:
Fh.tri.recruitment@adventhealth.com
Investigator:
Last name:
Bret Goodpaster, PhD
Email:
Principal Investigator
Investigator:
Last name:
Tarek Mekhail, MD
Email:
Sub-Investigator
Start date:
June 3, 2024
Completion date:
May 2025
Lead sponsor:
Agency:
AdventHealth Translational Research Institute
Agency class:
Other
Source:
AdventHealth Translational Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06008977
https://www.adventhealthresearchinstitute.com/research/translational-research
