NCT05708352

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-27
• Primary completion: 2028-09-30
• Completion: 2029-09-30
• First posted: 2023-02-01
• Last updated: 2025-12-24

Locations

5 sites across 1 country: United States