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

NCT06236360 | Unknown

• 1 other identifier: 8.1-23/262-6
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Melanoma Stage Iv; Metastatic Melanoma

Keywords

melanoma; immunotherapy; metastasis; mediterranean diet

Outcome Measures

Primary Outcomes (5)

• Change in the level of ingested flavones

  To evaluate the effectiveness and applicability of a tele-individualized nutritional intervention based on the Mediterranean diet (INIMP) to increase the intake of micronutrients (flavones)

  From enrollment to the end of treatment at 12 weeks

• Change in the level of ingested anthocyanins

  To evaluate the effectiveness and applicability of a tele-individualized nutritional intervention based on the Mediterranean diet (INIMP) to increase the intake of micronutrients (anthocyanin)

  From enrollment to the end of treatment at 12 weeks

• Change in the level of ingested omega-3 fatty acids

  To evaluate the effectiveness and applicability of a tele-individualized nutritional intervention based on the Mediterranean diet (INIMP) to increase the intake of micronutrients (omega-3 fatty acids)

  From enrollment to the end of treatment at 12 weeks

• Change in the level of ingested vitamin D

  To evaluate the effectiveness and applicability of a tele-individualized nutritional intervention based on the Mediterranean diet (INIMP) to increase the intake of micronutrients (vitamin D)

  From enrollment to the end of treatment at 12 weeks

• Change in the level of ingested fibre

  To evaluate the effectiveness and applicability of a tele-individualized nutritional intervention based on the Mediterranean diet (INIMP) to increase the intake of micronutrients (fibre)

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (4)

• A change in radiological response rate (PET/CT or CT)

  From enrollment to the end of treatment at 12 weeks

• A change in gut microbiome strains associated with an improved response to immunotherapy

  From enrollment to the end of treatment at 12 weeks

• A change in the quality of life assessed by EORTC QLQ C15-PAL

  From enrollment to the end of treatment at 12 weeks

• A change of biochemical biomarkers of melanoma (S100 and LDH)

  From enrollment to the end of treatment at 12 weeks

Other Outcomes (3)

• A change of concentration of microbiome associated with a good immune response

  From enrollment to the end of treatment at 12 weeks

• A correlation between microbiome associated with a good immune response and response

  From enrollment to the end of treatment at 12 weeks

• A correlation between microbiome associated with a good immune response and less adverse effects

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Mediterranean diet intervention

EXPERIMENTAL

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.

Behavioral: Mediterranean Diet Intervention

Continuing with previous diet

NO INTERVENTION

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)

Interventions

Mediterranean Diet Intervention BEHAVIORAL

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.

Mediterranean diet intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Rijeka: lead

Study Sites (1)

University Hospital Zagreb-Rebro

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Davorin Herceg, MD, PhD

  CHC Zagreb

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marin Golčić, MD, PhD

CONTACT

385-658-431; marin.golcic@gmail.com

Luka Simetić, MD

CONTACT

385-0124-20005; luka.doc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators/care providers will be masked, while investigators performing nutritional interventions will not.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy lead investigator

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: February 1, 2024
• Study Start: December 21, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after 3 months from study termination up to 12 months later
• Access Criteria: Following an official claim and review by a local Ethics Committee

Locations

CR (1)