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RECRUITING
NCT05708352
PHASE2

A Phase 2 Study of the Ketogenic Diet vs Standard Anti-cancer Diet Guidance for Patients With Glioblastoma in Combination With Standard-of-care Treatment

Sponsor: Cedars-Sinai Medical Center

View on ClinicalTrials.gov

Summary

This is a Phase 2, randomized two-armed, multi-site study of 170 patients with newly diagnosed glioblastoma multiforme. Patients will be randomized 1:1 to receive Keto Diet, or Standard Anti-Cancer Diet. All patients will receive standard of care treatment for their glioblastoma. The Keto Diet intervention will be for an 18-week period and conducted by trained research dietitians. Daily ketone and glucose levels will be recorded to monitor Keto Diet adherence. This two-armed randomized multi-site study aims to provide evidence to support the hypothesis that a Keto Diet vs. Standard Anti-Cancer Diet improves overall survival in newly diagnosed glioblastoma multiforme patients who receive standard of care treatment.

Official title: A Randomized Controlled Phase 2 Study of the Ketogenic Diet Versus Standard Dietary Guidance for Patients With Newly Diagnosed Glioblastoma in Combination With Standard-of-care Treatment

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2023-06-27

Completion Date

2029-09-30

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

BEHAVIORAL

Keto Diet

The experimental intervention includes a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption.

BEHAVIORAL

Standard Anti-Cancer Diet

Dietitian sessions will utilize the American Institute for Cancer Research Food resources and will reference foods low in fats such as fruits, vegetables and whole grains, providing key micronutrients and phytonutrients. Sessions will also focus on dietary support to help decrease any treatment related symptoms.

Locations (5)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Pacific Neuroscience Institute / Saint John's Cancer Institute

Santa Monica, California, United States

Duke University

Durham, North Carolina, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States