A Randomized Controlled Phase 2 Study of the Ketogenic Diet Versus Standard Dietary Guidance for Patients With Newly Diagnosed 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 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.
• 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.