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Not yet recruiting NCT07437300

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

— Observational Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Primary outcome measures

  • 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 [Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings]
Secondary outcome measures (10)
  • association between a high-fiber diet and the occurrence of immunotoxicity [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 [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 [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 [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 [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 [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 [Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings]
  • ssociation between alcohol consumption and response 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 [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 [Time frame: follow-up imaging at 3 and 6 months in curative and adjuvant settings]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07437300 · 38RC25.0434 · ID-RCB number

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗