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
Glioblastoma Multiforme
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Keto Diet
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- Cedars-Sinai Medical CenterRecruiting
- University of California, San Francisco
- Pacific Neuroscience Institute / Saint John's Cancer Institute
- Duke University
- Baylor Scott & White Health
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Keto-Diet
Standard Anti-Cancer Diet
Intensive 18-week Keto Diet intervention.
Standard Anti-Cancer Diet with Dietitian support