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

NCT06236360 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-01

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Mediterranean Diet Intervention

The primary goal is to evaluate whether tele-intervention can elevate the level of flavonoids, anthocyanins, proteins, omega-3 fatty acids, short fatty acids, fruits and vegetables, and fibers (all previously associated with a better response to immunotherapy) and limit foods with added sugars.

Sponsors & Collaborators

  • University Hospital Rijeka

    lead OTHER

Principal Investigators

  • Davorin Herceg, MD, PhD · CHC Zagreb

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2024-12-01
Completion
2025-12-01

Countries

  • Croatia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06236360 on ClinicalTrials.gov