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

NCT05708352 | Recruiting Phase 2 DMC

• 2 other identifiers: IIT2022-06-HU-DIET2TREATR01CA276919
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 5

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.

Conditions

Glioblastoma Multiforme

Keywords

Keto Diet

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  From Baseline to 18 Months

Secondary Outcomes (7)

• Health-related quality of life 1

  From Baseline to 18 Weeks

• Health-related quality of life 2

  From Baseline to 18 Weeks

• Progression-free survival

  From Baseline to 18 Weeks

• Cognitive performance 1

  From Baseline to 18 Weeks

• Cognitive performance 2

  From Baseline to 18 Weeks

Study Arms (2)

Keto-Diet

EXPERIMENTAL

Intensive 18-week Keto Diet intervention.

Behavioral: Keto Diet

Standard Anti-Cancer Diet

PLACEBO COMPARATOR

Standard Anti-Cancer Diet with Dietitian support

Behavioral: Standard Anti-Cancer Diet

Interventions

Standard Anti-Cancer Diet BEHAVIORAL

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.

Standard Anti-Cancer Diet

Keto Diet BEHAVIORAL

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.

Keto-Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Cedars-Sinai Medical Center: lead

Study Sites (5)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Pacific Neuroscience Institute / Saint John's Cancer Institute

Santa Monica, California, 90404, United States

RECRUITING

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

WITHDRAWN

MeSH Terms

Conditions

Glioblastoma

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jethro Hu, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Recruitment Navigator

CONTACT

3104232133; GroupCancerTrialInformation@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 1, 2023
• Study Start: June 27, 2023
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)