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A Phase 2 Study of the Ketogenic Diet vs Standard Diet Guidance for Patients With Glioblastoma in Combination With Standard-of-care Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05708352
Recruitment Status : Not yet recruiting
First Posted : February 1, 2023
Last Update Posted : May 12, 2023
Sponsor:
Information provided by (Responsible Party):
Jethro Hu, Cedars-Sinai Medical Center

Study Description
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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 Usual 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. usual diet improves overall survival in newly diagnosed glioblastoma multiforme patients who receive standard of care treatment.


Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Behavioral: Keto Diet Behavioral: Usual Diet Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : April 2028
Estimated Study Completion Date : April 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Keto-Diet
Intensive 18-week Keto Diet intervention.
 Behavioral: Keto 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.
Placebo Comparator: Usual Diet
Usual Diet with Dietitian support
 Behavioral: Usual 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.


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 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 :
  1. Health-related quality of life 1 [ Time Frame: 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.

  2. Health-related quality of life 2 [ Time Frame: 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.

  3. Progression-free survival [ Time Frame: 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.

  4. Cognitive performance 1 [ Time Frame: 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.

  5. Cognitive performance 2 [ Time Frame: 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.

  6. Physical activity [ Time Frame: From Baseline to 18 Weeks ]
    Measured by changes in the modified Godin leisure questionnaire survey scores. The more minutes per week spent in exercise the better the physical activity.

  7. Physical activity [ Time Frame: From Baseline to 18 Weeks ]
    Measured by Fitbit data changes. The higher the step count the better the physical activity.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05708352


Contacts
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Contact: Clinical Trial Recruitment Navigator 3104232133 cancer.trial.info@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Contact: Clinical Trial Recruitment Navigator    310-423-2133    cancer.trial.info@cshs.org   
Contact: Jethro Hu    310 423 8100    jethro.hu@cshs.org   
Principal Investigator: Stephen Freedland, MD         
Sub-Investigator: Gillian Gresham, PhD         
Sub-Investigator: Mourad Tighiouart, PhD         
Sub-Investigator: Sungyong You, PhD         
Sub-Investigator: LJ Amaral, MS, RD, CSO         
Sub-Investigator: Jeremy Rudnick, MD         
Sub-Investigator: John Yu, MD         
Sub-Investigator: Chirag Patil, MD         
Sub-Investigator: Ray Chu, MD         
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Nicholas Butowski, MD    415-353-2302    Nicholas.butowski@ucsf.edu   
Pacific Neuroscience Institute / Saint John's Cancer Institute
Santa Monica, California, United States, 90404
Contact: Santosh Kesari, MD, PhD    310-829-8265    kesaris@jwci.org   
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Contact: Katherine Peters, MD, PhD    919-684-5301    katherine.peters@duke.edu   
Sub-Investigator: Lin Pao-Hwa, PhD         
Sub-Investigator: Jen-Tsan Chi, MD, PhD         
United States, Texas
Baylor Scott & White Health
Temple, Texas, United States, 76508
Contact: Ekokobe Fonkem, DO    254-724-9786    ekokobe.fonkem@BSWHealth.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Jethro Hu, MD Cedars-Sinai Medical Center
More Information
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Responsible Party: Jethro Hu, Sponsor-Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT05708352    
Other Study ID Numbers: IIT2022-06-HU-DIET2TREAT
R01CA276919 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2023    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jethro Hu, Cedars-Sinai Medical Center:
Keto Diet
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue