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

Cedars-Sinai Medical Center

Status and phase: Enrolling; Phase 2

Conditions: Glioblastoma Multiforme

Treatments: Behavioral: Keto Diet; Behavioral: Standard Anti-Cancer Diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05708352

R01CA276919 (U.S. NIH Grant/Contract)

IIT2022-06-HU-DIET2TREAT

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups, including a placebo group

Keto-Diet

Experimental group

Description:

Intensive 18-week Keto Diet intervention.

Treatment:

Behavioral: Keto Diet

Standard Anti-Cancer Diet

Placebo Comparator group

Description:

Standard Anti-Cancer Diet with Dietitian support

Treatment:

Behavioral: Standard Anti-Cancer Diet