Comparing a Ketogenic Diet to a Standard Anti-Cancer Diet for Glioblastoma Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 study involves 170 patients with newly diagnosed glioblastoma multiforme who will be randomly assigned to either a Ketogenic Diet or a Standard Anti-Cancer Diet while receiving standard treatment. The intervention will last for 18 weeks, with trained dietitians overseeing the dietary adherence and monitoring daily ketone and glucose levels. The goal is to determine if the Ketogenic Diet can improve overall survival compared to the standard diet in these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Pacific Neuroscience Institute / Saint John's Cancer Institute
  Santa Monica, California, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting
• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Withdrawn

Study contacts

• Principal investigator: Jethro Hu, MD — Cedars-Sinai Medical Center
• Study coordinator: Clinical Trial Recruitment Navigator
• Email: GroupCancerTrialInformation@cshs.org
• Phone: 310-423-5842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.