A Randomized Controlled Phase II Study of the Ketogenic Diet Versus Standard Dietary Guidance for Patients With Newly Diagnosed Glioblastoma in Combination with Standard-of-Care Treatment
Summary
This is randomized multi-site phase II clinical trial that aims to assess whether a ketogenic diet improves overall survival in newly diagnosed glioblastoma patients who receive standard of care treatment when compared to the standard anti-cancer diet.
The ketogenic diet is proportionally higher in fat, significantly lower in carbs, and has adequate protein. This dietary combination decreases available glucose in the blood and increases the production of ketone bodies through the breakdown of fatty acids. These ketone bodies, which can cross the blood-brain barrier, become a critical energy source for the brain when glucose availability is low. Limiting circulating blood glucose supply while conversely elevating circulating ketone bodies via dietary intervention may stop cancer cell proliferation.
- 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.
For the most up-to-date list of criteria, please visit clinicaltrials.gov.
- 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, and 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 the ketogenic 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.
For the most up-to-date list of criteria, please visit clinicaltrials.gov.
