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

Launched by CEDARS-SINAI MEDICAL CENTER · Jan 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a Ketogenic Diet compared to a Standard Anti-Cancer Diet in patients with newly diagnosed glioblastoma multiforme, a type of brain cancer. The goal is to see if following a Ketogenic Diet can help improve overall survival when combined with standard cancer treatments like chemotherapy and radiation. The study involves 170 participants who will be randomly assigned to either diet for 18 weeks, while all will receive standard medical care for their cancer. Researchers will keep track of participants' daily ketone and glucose levels to ensure they are following the Keto Diet correctly.

To be eligible for this trial, participants must be adults aged 18 or older, recently diagnosed with glioblastoma (within two months), and have not yet started standard treatments. They should also be able to understand English or Spanish and give written consent to join the study. Participants can expect regular check-ins and support from trained dietitians during the trial. It's important to note that some individuals, such as those with certain genetic disorders, pregnant women, or those with specific health conditions, may not qualify to participate. Overall, this study aims to provide valuable information about dietary options that could potentially benefit patients facing this challenging diagnosis.

Gender

ALL

Eligibility criteria

• 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