Influence of a High-fiber Diet on the Microbiota and the Response to Immunotherapy in Patients Treated for Melanoma.

N/ANot Yet RecruitingNCT07437300

University Hospital, Grenoble60 enrolled

Overview

The underlying hypothesis of the study is that melanoma patients treated with immunotherapy, whether in an adjuvant or curative setting, who consume more fiber would respond better to immunotherapy: either no recurrence in the case of adjuvant treatments, or no progression (disease stability, partial or complete response) in the case of curative treatments. The primary objective is to evaluate the association between total dietary fiber intake quantified using the FiberTAG questionnaire and response to immunotherapy treatment in patients treated for melanoma in a curative or adjuvant setting

Study Type

OBSERVATIONAL

Enrollment

Conditions

Melanoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Melanoma treated with curative immunotherapy (IPILIMUMAB + NIVOLUMAB or NIVOLUMAB or PEMBROLIZUMAB or NIVOLUMAB + RELATLIMAB) or adjuvant immunotherapy (NIVOLUMAB or PEMBROLIZUMAB) * Patients monitored and treated at the dermatology day hospital at Grenoble Alpes University Hospital * Obtaining the patient's consent * Start of immunotherapy less than or equal to 1 year at the time of inclusion * Subject affiliated with social security system Exclusion Criteria: * Recurrence of the disease within 6 months or less after a first line of adjuvant treatment with immunotherapy for 1 year * Immunotherapy as a third line of treatment in metastatic situations * Squamous cell carcinoma or basal cell carcinoma treated with immunotherapy * Inability to complete the FiberTAG and GPAQ questionnaires (advanced neurocognitive disorders, memory loss, etc.) * Inclusion in an interventional clinical study * Immunotherapy in a neoadjuvant situation * Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social care institution for purposes other than research, minors, persons subject to legal protection measures or unable to give their consent). persons subject to legal protection measures)

Outcomes

Primary Outcomes

Association between total dietary fiber intake based on the FiberTAG questionnaire and response to immunotherapy treatment in patients treated for melanoma in a curative or adjuvant setting

Objective response rate to immunotherapy according to RECIST 1.1 criteria

Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

Secondary Outcomes

association between a high-fiber diet and the occurrence of immunotoxicity

Occurrence of immunotoxicity with its CTCAE v5.0

Time frame: during 6 months of immunotherapy initiation

association between muscle surface index on L3 CT scan using ODIASP software (Automated Computerized Muscle Surface Determination Tool at the Psoas Level) and response to immunotherapy

Muscle surface index on L3 CT scan using ODIASP software and objective response rate to immunotherapy

Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

association between the presence of malnutrition at the start of treatment and response to immunotherapy

Presence of malnutrition at the start of treatment and objective response rate to immunotherapy

Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

association between high physical activity (GPAQ (Global Physical Activity Questionnaire) score) and response to immunotherapy

High physical activity (GPAQ score) and objective response rate to immunotherapy

Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

association between uncontrolled diabetes (HbA1c > 7%) and response to immunotherapy

Uncontrolled diabetes (HbA1c \> 7%) and objective response rate to immunotherapy

Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

association between antibiotic use in the 3 months prior to the start of treatment and response to immunotherapy

Antibiotic use within 3 months prior to the start of treatment and objective response rate to immunotherapy

Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

association between prebiotic or probiotic use and response to immunotherapy

Pre- or probiotic intake and objective response rate to immunotherapy

Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

ssociation between alcohol consumption and response to immunotherapy

Alcohol consumption and objective response rate to immunotherapy

Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

association between tobacco consumption and response to immunotherapy

Tobacco consumption and objective response rate to immunotherapy

Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

Association between the presence of a pet in the patient's home and response to immunotherapy

Presence of a pet in the patient's home and objective response rate to immunotherapy

Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings

Influence of a High-fiber Diet on the Microbiota and the Response to Immunotherapy in Patients Treated for Melanoma.

Overview

Conditions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts