Clinical trial NCT06627595: Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management
Official title: Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Immunotoxicity
Keywords: physical activity
melanoma
immunotherapy
anti-PD-1
anti-CTLA4
immunotoxicity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged 18 years or older, newly diagnosed with melanoma with an indication for treatment initiation by immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA4), in an adjuvant or metastatic setting. Only incident cases will be included. Patients treated at Montpellier University Hospital (CHU) or the Montpellier Cancer Institute (ICM)

Brief summary: Management of melanoma is based on primary excision of the tumor. In cases of melanoma with poor prognosis criteria, or when it is locally advanced or metastatic, there is an indication for the implementation of adjuvant therapy, which may, in this context, be immunotherapy.

Immunotherapies are treatments that have revolutionized the prognosis of patients with melanoma. These are therapies that work by stimulating the immune system to enhance the anti-tumor response. Their toxicities are represented by immune-mediated toxicities, similar to true autoimmune diseases.

Adapted physical activity as supportive care in oncology is expanding. From a pathophysiological perspective, physical activity is thought to modulate the immune system (by reducing inflammation, restoring immune surveillance, stimulating anti-tumor responses through the induction of T cell proliferation, modulating the gut microbiota, and influencing tumor microenvironment cells, etc.).

The modulation of the immune system by physical activity may also allow us to hypothesize a modulation of the toxicities induced by immune checkpoint inhibitors. We wish to study this hypothesis in patients with advanced melanoma who are candidates for immunotherapy.

Originality and Innovative Aspects:

Physical activity as supportive care in oncology has developed significantly in recent years. However, adapted physical activity (APA) is currently only offered at one center in France (CHU de Lille).

In addition to the probable impact on patients\&#39; quality of life, if we find evidence supporting a reduction in treatment-related toxicities for melanoma through physical activity, it would be even more interesting to introduce APA at the CHU of Montpellier.

Primary and Secondary 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\&#39; general condition through measurement of WHO status and BMI.

Assess the evolution of patients\&#39; general condition: WHO status and BMI at treatment introduction, after 3 months, and at 6 months of treatment.

Study the evolution of patients\&#39; 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\&#39; 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\&#39; 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\&#39;Aurelle.

Using the collected data on patients\&#39; 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\&#39; 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 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

Primary outcomes:
measure: Immunotoxicity
timeFrame: From the time of enrollment until 6 months following the initiation of treatment
Secondary outcomes:
measure: Efficacy of immunotherapy
timeFrame: From the time of enrollment until 6 months following the initiation of treatment
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier (ICM)
Study officials:
References: