Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Objectives: Primary

Objective: To analyze the association between the level of physical activity (estimated by the IPAQ questionnaire) at the initiation of immunotherapy and the occurrence of adverse effects at 6 months after starting treatment in adult patients with melanoma. Secondary Objectives: Analyze the association between physical activity level and treatment efficacy of immunotherapy in adult melanoma patients. Describe the quarterly evolution of patients\' general condition through measurement of WHO status and BMI. Assess the evolution of patients\' general condition: WHO status and BMI at treatment introduction, after 3 months, and at 6 months of treatment. Study the evolution of patients\' quality of life during their treatment based on their physical activity level, using the QLQ-C30 questionnaire. Preliminary study: We aim to evaluate the correlation between self-reported physical activity by patients and their actual physical activity. To obtain an objective measurement of patients\' physical activity level, we plan to work with the CARTIGEN platform and offer a small number of included patients (maximum of 50) to wear wrist actimeters for one week before treatment initiation. We will then analyze these data to determine patients\' baseline physical activity levels and compare them with the data collected via questionnaires. This is a prospective cohort study within the context of analytical epidemiological research. It is a bicentric study: CHRU Montpellier - Saint-Eloi Hospital and ICM Val d\'Aurelle. Using the collected data on patients\' physical activity levels (IPAQ questionnaire), we will compare two groups: patients who experienced immuno-toxicities without physical activity versus those with moderate or high physical activity. We will also analyze treatment efficacy in these two groups, patients\' quality of life, and the evolution of their general condition. Procedure: Inclusion is planned at day 0 (D0), with physical activity (IPAQ3) and quality of life (QLQ-C30) questionnaires, along with clinical and oncological evaluation. A follow-up visit at month 3 (M3) will include reassessment of clinical and oncological status, followed by another visit at month 6 (M6) for further clinical, oncological, physical activity, and quality of life reassessment. The inclusion period is expected to last 18 months. Outcomes / Perspectives: If we consider that physical exercise may help mitigate the toxic effects of treatments-an aspect we wish to explore through this project-it would be relevant to introduce adapted physical activity (APA) sessions supervised by a specialized instructor within the Dermatology Day Hospital at the CHU of Montpellier. Implementing APA in the context of onco-dermatology will strengthen the multidisciplinary approach of the CHU. Collaboration between healthcare professionals, including specialized APA instructors, will foster effective care coordination. This initiative is part of a holistic approach to patient care, integrating complementary interventions to address physical, psychological, and social needs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Montpellier
RECRUITING
Montpellier
Institut du Cancer de Montpellier (ICM)
NOT_YET_RECRUITING
Montpellier
Contact Information
Primary
Alexandre Maria, MD, PhD
a-maria@chu-montpellier.fr
00330665849253
Backup
Quentin Samaran, MD, MSc
q-samaran@chu-montpellier.fr
00330467336906
Time Frame
Start Date: 2024-11-05
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 160
Treatments
Patients with no physical activity / low physical activity
Patients with low score according to the IPAQ questionnaire at baseline. This is the lowest level of physical activity.
Patients with moderate to high physical activity
Patients with moderate or high score according to the IPAQ questionnaire at baseline.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov