Actively Recruiting
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
Led by Cedars-Sinai Medical Center · Updated on 2026-05-06
170
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Cedars-Sinai Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a Ketogenic Diet versus a Standard Anti-Cancer Diet in patients newly diagnosed with glioblastoma multiforme. This Phase 2 randomized study involves 170 patients who all will receive standard of care treatment for their glioblastoma. The study aims to determine if the Keto Diet improves overall survival compared to the Standard Anti-Cancer Diet when combined with usual treatments. Participants are randomly assigned to one of two groups: an intensive 18-week Keto Diet managed by trained research dietitians, or a Standard Anti-Cancer Diet guided by dietitians using resources focused on low-fat foods like fruits, vegetables, and whole grains. Both groups receive dietitian support, and the Keto Diet group will track daily ketone and glucose levels to monitor adherence. During the study, participants undergo various assessments including overall survival monitored up to 18 months from the start, health-related quality of life evaluations, progression-free survival, cognitive performance tests, and physical activity measurements for up to 18 weeks. Researchers will also monitor adherence to the dietary interventions and safety throughout the study period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or higher
- Ability to read, write, and understand English or Spanish
- Written informed consent obtained and ability to comply with study requirements
You will not qualify if you...
- Patients with recurrent glioblastoma
- Genetic disorders affecting lipid metabolism, including pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects
- Inability to reduce steroid use below 8mg dexamethasone per day or equivalent
- Body Mass Index (BMI) less than 21 kg/m2 unless deemed safe by the Principal Investigator
- Currently pregnant or nursing
- Receiving other experimental therapies (off-label therapy allowed)
- Comorbidities limiting ability to complete the study
- Food preferences incompatible with Keto Diet
- Use of pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids allowed) unless deemed safe by the Principal Investigator
- Inability to participate in standard of care MRIs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 weeks
Participants follow either an intensive 18-week ketogenic diet or standard anti-cancer diet guidance alongside standard-of-care treatment for glioblastoma.
Regular dietitian sessions during the 18-week intervention
Duration - Up to 18 months from baseline
Participants are monitored for overall survival and health outcomes up to 18 months from baseline after completion of dietary intervention.
Visits based on standard clinical follow-up schedules
Trial Site Locations
Total: 5 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Pacific Neuroscience Institute / Saint John's Cancer Institute
Santa Monica, California, United States, 90404
Actively Recruiting
4
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
5
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Withdrawn
Research Team
C
Clinical Trial Recruitment Navigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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