Effects of physical activity on side effects from melanoma immunotherapy
Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management
This study is testing whether staying active can help melanoma patients feel better and experience fewer side effects while receiving immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Trial ID | NCT06627595 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how physical activity may influence the immune-related toxicities experienced by melanoma patients undergoing immunotherapy. It focuses on patients who are starting treatment with anti-PD-1 or a combination of anti-PD-1 and anti-CTLA4 therapies. The study aims to understand the potential benefits of adapted physical activity as supportive care in enhancing immune responses and reducing inflammation. By examining the relationship between physical activity and immunotherapy side effects, the study seeks to provide insights into improving patient management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed melanoma who are about to start immunotherapy.
Not a fit: Patients with active autoimmune diseases or other medical contraindications to immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help reduce the side effects of immunotherapy in melanoma patients, improving their quality of life during treatment.
How similar studies have performed: While the role of physical activity in cancer care is gaining attention, this specific approach to managing immunotherapy-induced toxicities in melanoma is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18 years or above * ECOG performance status inferior or equal to 3 * patient with a melanoma confirmed histologically/pathologically * indication for initiating treatment with anti-PD1 immunotherapy or anti-PD1 + anti-CTLA4 Exclusion Criteria: * patient unable to read and/or write * inability to follow up with the patient during the study period * refusal to participate after a reflection period * medical contraindication to initiating immunotherapy (active autoimmune disease requiring systemic treatment in the past 2 years, active infection, etc.) * not affiliated with a social security system * patient under legal protection, guardianship, or curatorship * person participating in another study that includes an ongoing exclusion period
Where this trial is running
Montpellier and 1 other locations
- CHU de Montpellier — Montpellier, France (Recruiting)
- Institut du Cancer de Montpellier (ICM) — Montpellier, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Alexandre Maria, MD, PhD
- Email: a-maria@chu-montpellier.fr
- Phone: 00330665849253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.