Influence of a High-fiber Diet on the Microbiota and the Response to Immunotherapy in Patients Treated for Melanoma.
Starting soon
Conditions studied: Melanoma
In brief
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
Key facts
- Study ID
- NCT07437300
- Run by
- University Hospital, Grenoble
- People needed
- 60
- Starts
- 2026-02-25
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Full record on ClinicalTrials.gov
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