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
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Croatia
University Hospital Zagreb-Rebro
RECRUITING
Zagreb
Contact Information
Primary
Marin Golčić, MD, PhD
marin.golcic@gmail.com
385-658-431
Backup
Luka Simetić, MD
luka.doc@gmail.com
385-0124-20005
Time Frame
Start Date:2023-12-21
Estimated Completion Date:2025-12-01
Participants
Target number of participants:30
Treatments
Experimental: Mediterranean diet intervention
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.
No_intervention: Continuing with previous diet
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)