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.

Eligibility

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

Conditions2

Locations5 sites

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