Clinical trial · Interventional
Metastatic Melanoma Patients on Immunotherapy With Nutritive Intervention Based on Mediterranean Diet
The Effect of Individualized Nutritive Intervention Based on the Mediterranean Diet on the Changes in the Gut Microbiome, Quality of Life, and Radiological and Biochemical Response to Immunotherapy in Metastatic Melanoma Patients
- 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)
This research will study the effect of Mediterranean diet intervention in patients undergoing immunotherapy treatment for metastatic melanoma and its relationship with gut microbiome and quality of life. One group of patients will continue with their regular diet, while the other will receive dietary tele-intervention with trained nutritionist during the 12-week period. Gut microbiome, quality of life questionnaires, blood parameters and radiological examination will be evaluated before and 12-weeks after the start of the intervention.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mediterranean Diet Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mediterranean diet intervention
- description
- The intervention study will involve scheduled communications (via phone, video call, and/or email) with a trained nutritionist based on protocol-determined parameters and recommendations, organized weekly in the first month, every other week in the second month, and once a month in the third month. Each patient will receive general guidance and information about the MD. Additionally, a personalized nutritional plan based on the MD will be prepared for each patient, considering their initial dietary habits, preferences, food accessibility, and financial constraints. Throughout the 12-week period, patients will be motivated to adhere to the prescribed dietary regimen.
- interventionNames
- Behavioral: Mediterranean Diet Intervention
- type
- NO_INTERVENTION
- label
- Continuing with previous diet
- description
- The control group will continue with their usual/current diet, with the exception of supplementation of those in whom low serum vitamin D level (in accordance with current medical recommendations)
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥18 years * pathophysiologically confirmed cutaneous melanoma stage IV or inoperable stage IIIC, * radiologically measurable disease on computerized tomography (CT) or positron emission tomography (PET)/CT, * The multidisciplinary team recommended initiation of treatment with dual immunotherapy with anti-PD-1 + anti-CTLA4 immunotherapy * written informed consent prior to participation * willingness to monitor and adjust the dietary regimen if necessary * Eastern Cooperative Oncology Group (ECOG) status 0-1. Exclusion Criteria: * lifetime history of psychiatric disorders * active brain metastases * active autoimmune disease * systemic use of equal or more than 10 mg of prednisone or an appropriate corticosteroid equivalent during screening * exposure to antibiotics and probiotics or other supplements that can affect the study outcome during screening within the last 3 weeks, * uncontrolled diabetes * history of clinically significant drug or alcohol abuse within the last 6 months * specific dietary habits that are not inclined or able to change or the existence of food allergy or intolerance to certain food * inability or refusal to participate in all research procedures
References
Publications (0)
Data not yet available