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

Phase 2RecruitingNCT05708352

Cedars-Sinai Medical Center170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

Glioblastoma Multiforme

Interventions

Standard Anti-Cancer DietBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Overall survival

Will be calculated as the number of days from the date of patient registration to the date of death.

Time frame: From Baseline to 18 Months

Secondary Outcomes

Health-related quality of life 1

Measured by changes in the Functional Assessment of Cancer Therapy - Brain (FACT-BR) survey scores. Scores can range from 0- 200, the higher the score the better the quality of life.