What is the Purpose of this Study?
The purpose of this study is to examine the effects of an 18-week ketogenic diet (high fat, moderate protein, very low carbohydrate diet) on overall survival of glioblastoma (a type of brain cancer). Researchers also aim to learn how biomarkers change when consuming a ketogenic diet. A biomarker is a biological molecule found in blood, other body fluids or tissues that may be a sign of a condition or disease and can be used to predict response to a specific treatment. Participants will be randomized into 1 of 2 groups. Group 1 will eat their usual diet, and Group 2 will eat a ketogenic diet. Both groups will receive regular diet advice and support from a trained study dietitian. Participants will also be asked to complete surveys, among other study procedures.
Eligibility
- * 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
Where can I participate?
- CS Cancer at Cedars-Sinai Medical Center : Ana Martin
- Duke University (Study Affiliate)
- Pacific Neuroscience Inst / St John's Cancer Inst (Study Affiliate)
- University of California, San Francisco (Study Affiliate)
More about this Clinical Trial
What is the full name of this clinical trial?
IIT2022-06-HU-DIET2TREAT: A Randomized Controlled Phase 2 Study of the Ketogenic Diet versus Standard Anti-Cancer Dietary Guidance for Patients with Newly Diagnosed Glioblastoma in Combination with Standard-of-Care Treatment