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 2

Recruiting

• Conditions: Glioblastoma Multiforme
• Interventions: Behavioral: Keto Diet; Behavioral: Standard Anti-Cancer Diet

• Registration Number: NCT05708352
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-02-01
• Study Start: 2023-06-27
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-15
• Primary Completion: 2028-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Keto-Diet	Keto Diet	Intensive 18-week Keto Diet intervention.
Standard Anti-Cancer Diet	Standard Anti-Cancer Diet	Standard Anti-Cancer Diet with Dietitian support

Primary Outcome Measures

Name	Time	Method
Overall survival	From Baseline to 18 Months	Will be calculated as the number of days from the date of patient registration to the date of death.

Secondary Outcome Measures

Name	Time	Method
Cognitive performance 2	From Baseline to 18 Weeks	Measured by changes in the Trail Marking Test A/B survey scores. The longer the task takes to complete the lower the cognitive performance.
Physical activity	From Baseline to 18 Weeks	Measured by Fitbit data changes. The higher the step count the better the physical activity.
Health-related quality of life 1	From Baseline to 18 Weeks	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.
Progression-free survival	From Baseline to 18 Weeks	Assessed with Magnetic resonance imaging (MRI) scan of the brain with and without gadolinium. MRI's will be reviewed and assessed for progression free survival via the modified Response Assessment in Neuro-Oncology Criteria.
Cognitive performance 1	From Baseline to 18 Weeks	Measured by changes in the Hopkins Verbal Test (HVLT-R) survey scores. Scores can range from 0-36, higher the scores the better the cognitive performance.
Health-related quality of life 2	From Baseline to 18 Weeks	Measured by changes in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey scores. Scores can range from 0- 160, the higher the score the better the quality of life.

Trial Locations

Locations (5)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Pacific Neuroscience Institute / Saint John's Cancer Institute; 🇺🇸 Santa Monica, California, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States