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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Glioblastoma Multiforme
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Santa Monica

Pacific Neuroscience Institute / Saint John's Cancer Institute, Santa Monica, California, United States, 90404

Durham

Duke University, Durham, North Carolina, United States, 27705

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cedars-Sinai Medical Center,

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

Study Record Dates

2029-06