Clinical trial · Observational
Influence of a High-fiber Diet on the Microbiota and the Response to Immunotherapy in Patients Treated for Melanoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- timeFrame
- follow-up imaging at 3 and 6 months in curative and adjuvant settings
- description
- Objective response rate to immunotherapy according to RECIST 1.1 criteria
Secondary outcomes (10)
- measure
- association between a high-fiber diet and the occurrence of immunotoxicity
- timeFrame
- during 6 months of immunotherapy initiation
- description
- Occurrence of immunotoxicity with its CTCAE v5.0
- measure
- 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
- timeFrame
- follow-up imaging at 3 and 6 months in curative and adjuvant settings
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available