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.
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
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
Cedars-Sinai Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator