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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
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
Conditions
Interventions
Dietary Intervention
Consume isocaloric whole foods diet higher in fiber
Dietary Intervention
Whole foods diet
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Locations (1)
M D Anderson Cancer Center
Houston, Texas, United States