RecruitingPhase 2NCT05708352

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

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

Sponsor

Cedars-Sinai Medical Center

Enrollment

170 participants

Start Date

Jun 27, 2023

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Multiforme

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria10

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

Interventions

BEHAVIORALKeto Diet

The experimental intervention includes a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption.

BEHAVIORALStandard Anti-Cancer Diet

Dietitian sessions will utilize the American Institute for Cancer Research Food resources and will reference foods low in fats such as fruits, vegetables and whole grains, providing key micronutrients and phytonutrients. Sessions will also focus on dietary support to help decrease any treatment related symptoms.