Dietary intervention based on the Mediterranean diet for melanoma patients on immunotherapy
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
This study is testing if following a Mediterranean diet can help melanoma patients on immunotherapy feel better and improve their treatment results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Rijeka Academic / other |
| Drugs / interventions | immunotherapy, prednisone |
| Locations | 1 site (Zagreb, Grad Zagreb) |
| Trial ID | NCT06236360 on ClinicalTrials.gov |
What this trial studies
This research investigates the impact of a Mediterranean diet on patients with metastatic melanoma who are receiving immunotherapy. Participants will be divided into two groups: one will maintain their usual diet while the other will receive dietary guidance from a nutritionist over a 12-week period. The study will assess changes in gut microbiome, quality of life, blood parameters, and radiological outcomes before and after the intervention. The goal is to explore whether dietary modifications can enhance the effectiveness of immunotherapy in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed stage IV or inoperable stage IIIC cutaneous melanoma who are starting dual immunotherapy.
Not a fit: Patients with active brain metastases, uncontrolled autoimmune diseases, or significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve treatment outcomes and quality of life for patients undergoing immunotherapy for metastatic melanoma.
How similar studies have performed: While dietary interventions in cancer treatment are being explored, this specific approach combining the Mediterranean diet with immunotherapy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zagreb, Grad Zagreb
- University Hospital Zagreb-Rebro — Zagreb, Grad Zagreb, Croatia (Recruiting)
Study contacts
- Principal investigator: Davorin Herceg, MD, PhD — CHC Zagreb
- Study coordinator: Marin Golčić, MD, PhD
- Email: marin.golcic@gmail.com
- Phone: 385-658-431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.