Actively Recruiting
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
Led by Cedars-Sinai Medical Center · Updated on 2026-05-06
170
Participants Needed
5
Research Sites
326 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
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.
CONDITIONS
Official 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 confirmed by histopathology
- Have not started standard chemotherapy or radiation therapy for glioblastoma
- Karnofsky Performance Status of 70 or higher
- Ability to read, write, and understand English or Spanish
- Able and willing to provide written informed consent and 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, or beta-oxidation defects
- Unable to reduce steroid dose below 8 mg dexamethasone daily or equivalent
- Body Mass Index below 21 kg/m2 unless approved by principal investigator
- Currently pregnant or nursing
- Receiving other experimental therapies (off-label use allowed)
- Comorbidities limiting ability to complete the study
- Food preferences incompatible with ketogenic diet
- Use of pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (except removable hearing aids) unless deemed safe by principal investigator
- Unable to participate in standard of care MRIs
AI-Screening
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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
CONTACT
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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