RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2023-06-27
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05708352

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults 18 years or older
  2. * Newly diagnosed glioblastoma (Within 2 months of initial diagnosis by histopathology)
  3. * Not started standard of care chemotherapy and/or radiation therapy for glioblastoma
  4. * Karnofsky Performance Status (KPS) ≥ 70
  5. * Ability to read, write and understand either English OR Spanish
  6. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
  1. * Patients with recurrent glioblastoma
  2. * 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
  3. * Inability to wean steroids below 8mg dexamethasone / day or equivalent
  4. * Body Mass Index (BMI) \< 21kg/m2, unless the site Principal Investigator deems safe
  5. * Currently pregnant or nursing
  6. * Patients receiving other experimental therapy Note: Off-label therapy use is permitted
  7. * Comorbidities that in the opinion of the investigator limit the patient's ability to complete the study
  8. * Food preferences incompatible with keto diet
  9. * 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
  10. * Inability to participant in standard of care MRIs

Contacts and Locations

Study Contact

Clinical Trial Recruitment Navigator
CONTACT
3104232133
cancer.trial.info@cshs.org

Principal Investigator

Jethro Hu, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Pacific Neuroscience Institute / Saint John's Cancer Institute
Santa Monica, California, 90404
United States
Duke University
Durham, North Carolina, 27705
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-27
Study Completion Date2029-06

Study Record Updates

Study Start Date2023-06-27
Study Completion Date2029-06

Terms related to this study

Keywords Provided by Researchers

  • Keto Diet

Additional Relevant MeSH Terms

  • Glioblastoma Multiforme