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

Summary

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.

Interventions

• Keto Diet · BEHAVIORAL

  The experimental intervention includes a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption.

• Standard Anti-Cancer Diet · BEHAVIORAL

  Dietitian sessions will utilize the American Institute for Cancer Research Food resources and will reference foods low in fats such as fruits, vegetables and whole grains, providing key micronutrients and phytonutrients. Sessions will also focus on dietary support to help decrease any treatment related symptoms.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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 (5)

• Cedars-Sinai Medical Center, Los Angeles, California · RECRUITING
• University of California, San Francisco, San Francisco, California · RECRUITING
• Pacific Neuroscience Institute / Saint John's Cancer Institute, Santa Monica, California · RECRUITING
• Duke University, Durham, North Carolina · RECRUITING
• Medical College of Wisconsin, Milwaukee, Wisconsin · WITHDRAWN