Glioblastoma MultiformePhase 2NCT05708352
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
A Phase 2 study testing Keto Diet and Standard Anti-Cancer Diet in people with Glioblastoma Multiforme, run by Cedars-Sinai Medical Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Keto Diet and Standard Anti-Cancer Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Jun 2023to 30 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 4 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27705
Katherine Peters, MD, PhD, 919-684-5301, katherine.peters@duke.edu
Lin Pao-Hwa, PhD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator, 310-423-5842, GroupCancerTrialInformation@cshs.org
Jethro Hu, 310 423 8100, jethro.hu@cshs.org
- Withdrawn
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Nicholas Butowski, MD, 415-353-2302, Nicholas.butowski@ucsf.edu
- Recruiting
Pacific Neuroscience Institute / Saint John's Cancer Institute
Santa Monica, California, 90404
Akanksha Sharma, MD, 310-829-8265, Akanksha.Sharma@providence.org
About this study
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
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
- Being tested
- Keto Diet, Standard Anti-Cancer Diet
- Keywords
- Keto Diet
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keto DietBehavioural
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.
Standard Anti-Cancer DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Keto-Diet | Experimental | Intensive 18-week Keto Diet intervention. Receives: Behavioral: Keto Diet |
| Standard Anti-Cancer Diet | Placebo comparator | Standard Anti-Cancer Diet with Dietitian support Receives: Behavioral: Standard Anti-Cancer Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Will be calculated as the number of days from the date of patient registration to the date of death.
Measured: From Baseline to 18 Months
Secondary outcomes (7)
Health-related quality of life 1
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.
Measured: From Baseline to 18 Weeks
Health-related quality of life 2
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.
Measured: From Baseline to 18 Weeks
Progression-free survival
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.
Measured: From Baseline to 18 Weeks
Cognitive performance 1
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.
Measured: From Baseline to 18 Weeks
Cognitive performance 2
Measured by changes in the Trail Marking Test A/B survey scores. The longer the task takes to complete the lower the cognitive performance.
Measured: From Baseline to 18 Weeks
Physical activity
Measured by changes in the modified Godin leisure questionnaire survey scores. The more minutes per week spent in exercise the better the physical activity.
Measured: From Baseline to 18 Weeks
Physical activity
Measured by Fitbit data changes. The higher the step count the better the physical activity.
Measured: From Baseline to 18 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start27 Jun 2023
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jethro Hu, Cedars-Sinai Medical Center
- Investigators
- Jethro Hu, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708352
- Sponsor's protocol ID
- IIT2022-06-HU-DIET2TREAT
- Other IDs
- R01CA276919
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05708352
- Acronym / sponsor ID
- IIT2022-06-HU-DIET2TREAT
- Conditions
- Glioblastoma Multiforme
- Keywords
- Keto Diet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keto-Diet | Experimental | Behavioral: Keto DietIntensive 18-week Keto Diet intervention. |
| Standard Anti-Cancer Diet | Placebo comparator | Behavioral: Standard Anti-Cancer DietStandard Anti-Cancer Diet with Dietitian support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Keto DietThe 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. | Behavioural | Keto-Diet |
| Standard Anti-Cancer DietDietitian 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. | Behavioural | Standard Anti-Cancer Diet |
Primary outcome
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.
7 secondary outcomes
Health-related quality of life 1
Time frame: From Baseline to 18 Weeks
Health-related quality of life 2
Time frame: From Baseline to 18 Weeks
Progression-free survival
Time frame: From Baseline to 18 Weeks
Cognitive performance 1
Time frame: From Baseline to 18 Weeks
Cognitive performance 2
Time frame: From Baseline to 18 Weeks
Physical activity
Time frame: From Baseline to 18 Weeks
Physical activity
Time frame: From Baseline to 18 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jethro Hu, MD principal investigator
Cedars-Sinai Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Keto Diet and Standard Anti-Cancer Diet in people with Glioblastoma Multiforme, run by Cedars-Sinai Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Recruitment Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From Baseline to 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.