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

Last updated: February 14, 2025
Sponsor: Cedars-Sinai Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Gliomas

Glioblastoma Multiforme

Astrocytoma

Treatment

Usual Diet

Keto Diet

Standard Anti-Cancer Diet

Clinical Study ID

NCT05708352
IIT2022-06-HU-DIET2TREAT
R01CA276919
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults 18 years or older

  • Newly diagnosed glioblastoma (Within 2 months of initial diagnosis byhistopathology)

  • 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 complywith the requirements of the study.

Exclusion

Exclusion Criteria:

  • Patients with recurrent glioblastoma

  • Genetic disorders that affect lipid metabolism. Including but not limited topyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitinepalmitoyltransferase 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 ispermitted

  • Comorbidities that in the opinion of the investigator limit the patient's ability tocomplete the study

  • Food preferences incompatible with keto diet

  • Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlearimplants (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

Total Participants: 170
Treatment Group(s): 3
Primary Treatment: Usual Diet
Phase: 2
Study Start date:
June 27, 2023
Estimated Completion Date:
September 30, 2029

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Pacific Neuroscience Institute / Saint John's Cancer Institute

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Baylor Scott & White Health

    Temple, Texas 76508
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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