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

Recruiting now · Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT05708352

Run by

Cedars-Sinai Medical Center

People needed

170

Starts

2023-06-27

Expected to finish

2029-09-30

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 years or older
• Newly diagnosed glioblastoma (Within 2 months of initial diagnosis by histopathology)
• Not started standard of care chemotherapy and/or radiation therapy for glioblastoma
• Karnofsky Performance Status (KPS) ≥ 70
• Ability to read, write and understand either English OR Spanish
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

You may not qualify if…

• Patients with recurrent glioblastoma
• Genetic disorders that affect lipid metabolism. Including but not limited to pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects
• Inability to wean steroids below 8mg dexamethasone / day or equivalent
• Body Mass Index (BMI) < 21kg/m2, unless the site Principal Investigator deems safe
• Currently pregnant or nursing
• Patients receiving other experimental therapy Note: Off-label therapy use is permitted
• Comorbidities that in the opinion of the investigator limit the patient's ability to complete the study
• Food preferences incompatible with keto diet
• Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the site Principal Investigator deems safe
• Inability to participant in standard of care MRIs

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Pacific Neuroscience Institute / Saint John's Cancer Institute — Santa Monica, California, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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