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
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
Parallel
Keto Diet
BehavioralThe 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
BehavioralDietitian 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.
Overall survival
Will be calculated as the number of days from the date of patient registration to the date of death.
Health-related quality of life 1
Measured by changes in the Functional Assessment of Cancer Therapy - Brain (FACT-BR) survey scores. Scores can range from 0- 200, the higher the score the better the quality of life.
Health-related quality of life 2
Measured by changes in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey scores. Scores can range from 0- 160, the higher the score the better the quality of life.
Progression-free survival
Assessed with Magnetic resonance imaging (MRI) scan of the brain with and without gadolinium. MRI's will be reviewed and assessed for progression free survival via the modified Response Assessment in Neuro-Oncology Criteria.
Cognitive performance 1
Measured by changes in the Hopkins Verbal Test (HVLT-R) survey scores. Scores can range from 0-36, higher the scores the better the cognitive performance.
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Cedars-Sinai Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
