RECRUITING

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Conditions

Cutaneous Melanoma Cutaneous Squamous Cell Carcinoma Merkel Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Quick Facts

Study Start:2024-06-03

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06008977

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Recruitment Department

CONTACT

407-303-7100

Fh.tri.recruitment@adventhealth.com

Principal Investigator

Bret Goodpaster, PhD

PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Study Locations (Sites)

AdventHealth Translational Research Institute

Orlando, Florida, 32804

United States

Collaborators and Investigators

Sponsor: AdventHealth Translational Research Institute

Bret Goodpaster, PhD, PRINCIPAL_INVESTIGATOR, Study Principal Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-03

Study Completion Date2025-05

Study Record Updates

Study Start Date2024-06-03

Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

Cutaneous Melanoma
Cutaneous Squamous Cell Carcinoma
Merkel Cell Carcinoma