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ACTIVE NOT RECRUITING
NCT04645680
PHASE2

Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic Melanoma Receiving Immunotherapy

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, fully controlled feeding study that will enroll melanoma patients starting standard-of-care ICB in three settings: adjuvant, neoadjuvant, and unresectable. Patients are randomized to the high fiber or healthy control diet. The goal of the study is to establish the effects of dietary intervention on the structure and function of the gut microbiome in patients with melanoma treated with SOC immunotherapies.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2020-06-24

Completion Date

2026-02-28

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

OTHER

Dietary Intervention

Consume isocaloric whole foods diet higher in fiber

OTHER

Dietary Intervention

Whole foods diet

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States