Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Glioblastoma Multiforme, Keto Diet, Glioblastoma, Keto-Diet

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Pacific Neuroscience Institute / Saint John's Cancer Institute accepting new patients
    Santa Monica California 90404 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cedars-Sinai Medical Center
ID
NCT05708352
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 170 study participants
Last Updated