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
NCT ID: NCT05708352
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
170 participants
INTERVENTIONAL
2023-06-27
2029-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Keto-Diet
Intensive 18-week Keto Diet intervention.
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
Standard Anti-Cancer Diet with Dietitian support
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Cedars-Sinai Medical Center
OTHER
Responsible Party
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Jethro Hu
Sponsor-Investigator
Principal Investigators
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Jethro Hu, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Pacific Neuroscience Institute / Saint John's Cancer Institute
Santa Monica, California, United States
Duke University
Durham, North Carolina, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trial Recruitment Navigator
Role: primary
Jethro Hu
Role: backup
Nicholas Butowski, MD
Role: primary
Akanksha Sharma, MD
Role: primary
Katherine Peters, MD, PhD
Role: primary
Other Identifiers
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IIT2022-06-HU-DIET2TREAT
Identifier Type: -
Identifier Source: org_study_id