NCT05708352 · Cedars-Sinai Medical Center
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
What this study is about
This is a Phase 2, randomly assigned two-armed, multi-site study of 170 patients with newly diagnosed glioblastoma multiforme. Patients will be randomly assigned 1:1 to receive Keto Diet, or Standard Anti-Cancer Diet. All patients will receive the usual treatment treatment for their glioblastoma. The Keto Diet intervention will be for an 18-week period and conducted by trained research dietitians.
View original scientific description
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.
Interventions
BEHAVIORAL
Keto 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.
BEHAVIORAL
Standard 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.
Primary outcome measures
Overall survival
Time frame: From Baseline to 18 Months
Will be calculated as the number of days from the date of patient registration to the date of death.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 experimenta
Where
- Los Angeles, California
- San Francisco, California
- Santa Monica, California
- Durham, North Carolina
- Milwaukee, Wisconsin
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations