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

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 Usual 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. usual diet improves overall survival in newly diagnosed glioblastoma multiforme patients who receive standard of care treatment.

Inclusion Criteria:Adults 18 years or olderNewly diagnosed glioblastoma (Within 2 months of initial diagnosis by histopathology)Not started standard of care chemotherapy and/or radiation therapy for glioblastomaKarnofsky Performance Status (KPS) ≥ 70Ability to read, write and understand either English OR SpanishWritten informed consent obtained from subject and ability for subject to comply with the requirements of the study.Exclusion Criteria:Patients with recurrent glioblastomaGenetic 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 defectsInability to wean steroids below 8mg dexamethasone / day or equivalentBody Mass Index (BMI) < 21kg/m2, unless the site Principal Investigator deems safeCurrently pregnant or nursingPatients receiving other experimental therapy Note: Off-label therapy use is permittedComorbidities that in the opinion of the investigator limit the patient's ability to complete the studyFood preferences incompatible with keto dietUsing a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the site Principal Investigator deems safeInability to participant in standard of care MRIs