RecruitingPhase 2NCT05708352

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

Sponsor

Cedars-Sinai Medical Center

Enrollment

170 participants

Start Date

Jun 27, 2023

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Multiforme

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether following a ketogenic (very low-carb, high-fat) diet alongside standard radiation and chemotherapy can improve outcomes for patients newly diagnosed with glioblastoma, an aggressive type of brain cancer. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with glioblastoma (within the last 2 months, confirmed by biopsy) - You have not yet started chemotherapy or radiation for glioblastoma - You are physically functional enough to carry out daily activities (KPS score 70 or higher) - You can read and communicate in English or Spanish - You are willing to follow dietary guidelines for the duration of the study **You may NOT be eligible if...** - You have had glioblastoma before (recurrent disease) - You have a genetic condition that affects how your body processes fats - You require more than a certain dose of steroids and cannot reduce them - Your BMI is very low (under 21) unless cleared by the investigator - You are pregnant or breastfeeding - You have a pacemaker or certain implanted electronic devices Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALKeto 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.

BEHAVIORALStandard 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.