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Phase 2 Study of Ketogenic Diet vs. Standard Anti-cancer Diet for Glioblastoma

This study is looking at whether a special diet, called the Ketogenic Diet, can help people with newly diagnosed glioblastoma multiforme (a type of brain cancer) live longer when combined with their usual cancer treatments. You would be randomly assigned to follow either the Ketogenic Diet, which focuses on high fat and low carbohydrates, or a Standard Anti-Cancer Diet, which emphasizes fruits, vegetables, and whole grains. Researchers will compare how long people live in each diet group. To join, you must be an adult (18 or older) with newly diagnosed glioblastoma, have not yet started chemotherapy or radiation, and have a good performance status (Karnofsky Performance Status ≥ 70). The study aims to enroll 170 patients.

Study design
This is a Phase 2, randomized study involving 170 patients. You would be randomly assigned to one of two diet groups.
What's involved
If on the Keto Diet, you would follow it for 18 weeks and record daily ketone and glucose levels. You would also have dietitian sessions.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be measured for up to 18 months after starting the study.

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NCT05708352

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Cedars-Sinai Medical Center
~170 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Keto DietStandard Anti-Cancer Diet

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival
Measured over From Baseline to 18 Months

Conditions

Glioblastoma Multiforme

Explore related trials

Glioblastoma

Where it's being run

5 sites across 3 states
California3
North Carolina1
Wisconsin1

Study leadership

  • Jethro Hu, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Clinical Trial Recruitment Navigator
[email protected]
310-423-5842
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 experimental therapy Note: Off-label therapy use is permitted
Comorbidities that in the opinion of the investigator limit the patient's ability to complete the study
Food preferences incompatible with keto diet
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
Inability to participant in standard of care MRIs

What this trial measures

  • Overall survivalFrom Baseline to 18 Months

    Will be calculated as the number of days from the date of patient registration to the date of death.