Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-01-08 @ 3:40 PM
Study NCT ID:
NCT06627595
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2024-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunotoxicity', 'timeFrame': 'From the time of enrollment until 6 months following the initiation of treatment', 'description': 'Occurrence of immune-induced side effects'}], 'secondaryOutcomes': [{'measure': 'Efficacy of immunotherapy', 'timeFrame': 'From the time of enrollment until 6 months following the initiation of treatment', 'description': 'Tumoral response to immunotherapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'melanoma', 'immunotherapy', 'anti-PD-1', 'anti-CTLA4', 'immunotoxicity'], 'conditions': ['Melanoma', 'Immunotoxicity']}, 'descriptionModule': {'briefSummary': '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.\n\nImmunotherapies 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.\n\nAdapted 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.).\n\nThe 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.\n\nOriginality and Innovative Aspects:\n\nPhysical 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).\n\nIn addition to the probable impact on patients\\' 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.\n\nPrimary and Secondary Objectives:\n\nPrimary 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.\n\nSecondary Objectives:\n\nAnalyze the association between physical activity level and treatment efficacy of immunotherapy in adult melanoma patients.\n\nDescribe the quarterly evolution of patients\\' general condition through measurement of WHO status and BMI.\n\nAssess the evolution of patients\\' general condition: WHO status and BMI at treatment introduction, after 3 months, and at 6 months of treatment.\n\nStudy the evolution of patients\\' quality of life during their treatment based on their physical activity level, using the QLQ-C30 questionnaire.\n\nPreliminary study:\n\nWe 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.\n\nThis 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.\n\nUsing 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.\n\nWe will also analyze treatment efficacy in these two groups, patients\\' quality of life, and the evolution of their general condition.\n\nProcedure:\n\nInclusion is planned at day 0 (D0), with physical activity (IPAQ3) and quality of life (QLQ-C30) questionnaires, along with clinical and oncological evaluation.\n\nA 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.\n\nThe inclusion period is expected to last 18 months.\n\nOutcomes / Perspectives:\n\nIf 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.\n\nImplementing APA in the context of onco-dermatology will strengthen the multidisciplinary approach of the CHU.\n\nCollaboration between healthcare professionals, including specialized APA instructors, will foster effective care coordination.\n\nThis initiative is part of a holistic approach to patient care, integrating complementary interventions to address physical, psychological, and social needs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or above\n* ECOG performance status inferior or equal to 3\n* patient with a melanoma confirmed histologically/pathologically\n* indication for initiating treatment with anti-PD1 immunotherapy or anti-PD1 + anti-CTLA4\n\nExclusion Criteria:\n\n* patient unable to read and/or write\n* inability to follow up with the patient during the study period\n* refusal to participate after a reflection period\n* medical contraindication to initiating immunotherapy (active autoimmune disease requiring systemic treatment in the past 2 years, active infection, etc.)\n* not affiliated with a social security system\n* patient under legal protection, guardianship, or curatorship\n* person participating in another study that includes an ongoing exclusion period'}, 'identificationModule': {'nctId': 'NCT06627595', 'acronym': 'APiTOXMM', 'briefTitle': 'Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Impact of Physical Activity on Immunotherapy-induced Toxicities in Melanoma Management', 'orgStudyIdInfo': {'id': 'RECHMPL24_0195'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with no physical activity / low physical activity', 'description': 'Patients with low score according to the IPAQ questionnaire at baseline. This is the lowest level of physical activity.', 'interventionNames': ['Drug: Immunotherapy']}, {'label': 'Patients with moderate to high physical activity', 'description': 'Patients with moderate or high score according to the IPAQ questionnaire at baseline.', 'interventionNames': ['Drug: Immunotherapy']}], 'interventions': [{'name': 'Immunotherapy', 'type': 'DRUG', 'otherNames': ['pembrolizumab', 'nivolumab', 'ipilimumab'], 'description': 'Patients will be treated in accordance with the guidelines for melanoma treatment.', 'armGroupLabels': ['Patients with moderate to high physical activity', 'Patients with no physical activity / low physical activity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre Maria, MD, PhD', 'role': 'CONTACT', 'email': 'a-maria@chu-montpellier.fr', 'phone': '00330665849253'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Montpellier', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anouck Lamoureux, MD', 'role': 'CONTACT', 'email': 'a-lamoureux@chu-montpellier.fr', 'phone': '00330467336906'}], 'facility': 'Institut du Cancer de Montpellier (ICM)', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Alexandre Maria, MD, PhD', 'role': 'CONTACT', 'email': 'a-maria@chu-montpellier.fr', 'phone': '00330665849253'}, {'name': 'Quentin Samaran, MD, MSc', 'role': 'CONTACT', 'email': 'q-samaran@chu-montpellier.fr', 'phone': '00330467336906'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}