Recruiting
Phase 2

Ketogenic Diet vs. Standard Diet

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT05708352

Conditions

Glioblastoma Multiforme

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Keto Diet

Standard Anti-Cancer Diet

Study Details

Brief summary:

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

Glioblastoma Multiforme

Study ID

NCT05708352

Start date

Jun 27, 2023

Status verified date

Aug, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Keto-Diet

Intensive 18-week Keto Diet intervention.

placebo comparator: Standard Anti-Cancer Diet

Standard Anti-Cancer Diet with Dietitian support

Interventions

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.

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 measure

  • Overall survival [ Time Frame: From Baseline to 18 Months ]

Central Contacts and Locations

Central contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Jethro Hu

310 423 8100jethro.hu@cshs.org

Principal Investigator:

Stephen Freedland, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Nicholas Butowski, MD

415-353-2302Nicholas.butowski@ucsf.edu

Pacific Neuroscience Institute / Saint John's Cancer Institute

Recruiting

Santa Monica, California, United States, 90404

Contacts

Akanksha Sharma, MD

310-829-8265Akanksha.Sharma@providence.org

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Katherine Peters, MD, PhD

919-684-5301katherine.peters@duke.edu

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Keto Diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-08-05.