Metastatic Melanoma Patients on Immunotherapy With Nutritive Intervention Based on Mediterranean Diet

Launched by UNIVERSITY HOSPITAL RIJEKA · Jan 23, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how a Mediterranean diet might help patients with advanced melanoma (a serious skin cancer) who are receiving immunotherapy, a type of treatment that helps the body fight cancer. The study will involve two groups of patients: one group will continue to eat their regular diet, while the other will receive guidance and support from a nutritionist to follow a Mediterranean diet for 12 weeks. Researchers will look at how this diet affects the patients' gut health, overall quality of life, and the status of their cancer through various tests and questionnaires before and after the 12-week period.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with stage IV melanoma or a stage IIIC melanoma that cannot be surgically removed. They should also be starting treatment with a specific combination of immunotherapy. Participants will need to be willing to adjust their diet and complete all study procedures. It's important to note that those with certain medical conditions or dietary restrictions may not be eligible. This study aims to provide insights that could enhance treatment and quality of life for melanoma patients.

Gender

ALL

Eligibility 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