NCT05708352RecruitingPhase 2
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
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 12 Jan 2023
- Start date
- 27 Jun 2023
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Glioblastoma
- NCT number
- NCT05708352
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 170
- From 27 Jun 2023 to the primary completion date, 30 Sept 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to wean steroids below 8mg dexamethasone / day or equivalent
- Patients receiving other experimental therapy Note: Off-label therapy use is permitted
Other illness
- 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
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the site Principal Investigator deems safe
Other
- Patients with recurrent glioblastoma
- Body Mass Index (BMI) \< 21kg/m2, unless the site Principal Investigator deems safe
- Currently pregnant or nursing
- Comorbidities that in the opinion of the investigator limit the patient's ability to complete the study
- Food preferences incompatible with keto diet
- Inability to participant in standard of care MRIs
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Withdrawn |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Pacific Neuroscience Institute / Saint John's Cancer Institute Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.