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
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.
Arms & interventions
- BehavioralKeto Diet
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.
- BehavioralStandard Anti-Cancer Diet
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.
Outcome measures
Primary
Overall survival
Will be calculated as the number of days from the date of patient registration to the date of death.
Time frame: From Baseline to 18 Months
Secondary
Health-related quality of life 1
Time frame: From Baseline to 18 Weeks
Health-related quality of life 2
Time frame: From Baseline to 18 Weeks
Progression-free survival
Time frame: From Baseline to 18 Weeks
Cognitive performance 1
Time frame: From Baseline to 18 Weeks
Cognitive performance 2
Time frame: From Baseline to 18 Weeks
Physical activity
Time frame: From Baseline to 18 Weeks
Physical activity
Time frame: From Baseline to 18 Weeks
Eligibility criteria
Study locations (5)
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of California, San Francisco
San Francisco, California, 94143
Pacific Neuroscience Institute / Saint John's Cancer Institute
Santa Monica, California, 90404
Duke University
Durham, North Carolina, 27705
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226