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
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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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Physical activity [ Time Frame: From Baseline to 18 Weeks ]Measured by Fitbit data changes. The higher the step count the better the physical activity.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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
|Contact: Clinical Trial Recruitment Navigatorfirstname.lastname@example.org|
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Contact: Clinical Trial Recruitment Navigator 310-423-2133 email@example.com|
|Contact: Jethro Hu 310 423 8100 firstname.lastname@example.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.email@example.com|
|Pacific Neuroscience Institute / Saint John's Cancer Institute|
|Santa Monica, California, United States, 90404|
|Contact: Santosh Kesari, MD, PhD 310-829-8265 firstname.lastname@example.org|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Contact: Katherine Peters, MD, PhD 919-684-5301 email@example.com|
|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|
|Principal Investigator:||Jethro Hu, MD||Cedars-Sinai Medical Center|
|Responsible Party:||Jethro Hu, Sponsor-Investigator, Cedars-Sinai Medical Center|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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