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RecruitingInterventionalPhase 2

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

NCT ID: NCT05708352Sponsor: Cedars-Sinai Medical CenterLast updated: 2026-05-06

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.

Arms & interventions

  • BehavioralKeto 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.

  • BehavioralStandard 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.

Outcome measures

Primary

  • Overall survival

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

    Time frame: From Baseline to 18 Months

Secondary

  • Health-related quality of life 1

    Time frame: From Baseline to 18 Weeks

  • Health-related quality of life 2

    Time frame: From Baseline to 18 Weeks

  • Progression-free survival

    Time frame: From Baseline to 18 Weeks

  • Cognitive performance 1

    Time frame: From Baseline to 18 Weeks

  • Cognitive performance 2

    Time frame: From Baseline to 18 Weeks

  • Physical activity

    Time frame: From Baseline to 18 Weeks

  • Physical activity

    Time frame: From Baseline to 18 Weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (5)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Recruiting
Clinical Trial Recruitment Navigator · Contact
Jethro Hu · Contact
Stephen Freedland, MD · Principal Investigator
Gillian Gresham, PhD · Sub Investigator
Mourad Tighiouart, PhD · Sub Investigator
Sungyong You, PhD · Sub Investigator
LJ Amaral, MS, RD, CSO · Sub Investigator
Jeremy Rudnick, MD · Sub Investigator
John Yu, MD · Sub Investigator
Chirag Patil, MD · Sub Investigator
Ray Chu, MD · Sub Investigator

University of California, San Francisco

San Francisco, California, 94143

Recruiting
Nicholas Butowski, MD · Contact

Pacific Neuroscience Institute / Saint John's Cancer Institute

Santa Monica, California, 90404

Recruiting
Akanksha Sharma, MD · Contact

Duke University

Durham, North Carolina, 27705

Recruiting
Katherine Peters, MD, PhD · Contact
Lin Pao-Hwa, PhD · Sub Investigator
Jen-Tsan Chi, MD, PhD · Sub Investigator

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Withdrawn