GBMPhase 1NCT03451799
Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma
A Phase 1 study testing Ketogenic Diet, Standard-of-care radiation and Standard-of-care Temozolomide in people with GBM and Glioblastoma, run by Jethro Hu at 1 site in United States.
Trial summary
Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining protocol defined metabolic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GBM, Glioblastoma
- What is being tested?
- Ketogenic Diet, Standard-of-care radiation and Standard-of-care Temozolomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2018to 29 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 (age ≥ 18 years)
- Newly or recently diagnosed glioblastoma. Patients may enroll in the study from the time of diagnosis (prior to the initiation of standard-of-care chemoradiation) up until the initiation of post-radiation adjuvant chemotherapy (typically approximately 3-4 weeks after the completion of radiation therapy). Overall, this provides a window of approximately 3 months from the time of diagnosis for patients to enroll in this study. No recurrent glioblastoma is allowed on trial.
- Being seen for treatment of glioblastoma at Cedars-Sinai Medical Center. Note: Okay if patients receiving chemotherapy or radiation therapy at another facility
- Patients on low and managed doses of steroids are permitted. Up to 8 mg dexamethasone or steroid equivalent.
Who cannot join
- Karnofsky Performance Status of <70 as deemed by physician or equivalent
- Body Mass Index of <22 kg/m2 (rounded to nearest integer)
- Patients with disorders that affect lipid metabolism such as pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, Beta-Oxidation Defects
- Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
- Pregnant, nursing, or implanted with an intrauterine device (IUD) that is not MR compatible
- Patients who are vegan or vegetarian will be excluded, as the ketogenic diet includes foods that may interfere with these preferences
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- Patients on high doses of steroids will be excluded
- Patients currently receiving experimental therapeutic therapy will be excluded from the trial. Note: Off-label therapy use is permitted
- Inability to adhere to the protocol
- Patients with history of allergic reactions to surgical steel or elastomer/rubber are excluded from the activity monitor portion of the study. Because the activity monitor uses a Bluetooth low energy Transceiver, individuals using pacemakers, implantable cardiac defibrillators, neuro-stimulation devices, cochlear implants, hearing aids, or other electronic medical equipment should also be excluded from wearing the activity monitor. They can still use the Aria scale to record weight.
- Patients with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers, neurostimulators, and infusion pumps, that are not magnetic resonance imaging/positron emission tomography (MRI/PET) compatible.
- Patients with ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
- Patients unable to tolerate MRI/PET imaging secondary to an inability to lie supine or severe claustrophobia as assessed by the treating physician or principal investigator.
- Patients unable to lie still, hold their breath, or follow imaging procedure instructions as assessed by the treating physician or PI.
- Patients whose most recent renal function test does not meet Cedars-Sinai Medical center standard of care MRI contrast protocol requirements (glomerular filtration rate <45ml/min).
- Patients with a known allergy to Fludeoxyglucose F18 (F18-FDG) radioactive tracer or gadolinium-based contrast agent.
- Patients with allergy to animal dander or animal-instigated asthma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: IIT2016-17-HU-KETORADTMZ: A Phase 1 Study of a 4-month Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Newly/Recently Diagnosed Glioblastoma
Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining protocol defined metabolic ketosis. Subjects will be monitored for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.
Read the detailed description
Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will place patients on a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption. Dietitians will provide guidance and teaching of the diet, as well as, monitoring and diet adjustment to ensure metabolic ketosis. Dietitians and study physicians (and their staff) will monitor subjects for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.
- Conditions
- GBM, Glioblastoma
- Being tested
- Ketogenic Diet, Standard-of-care radiation, Standard-of-care Temozolomide
- Keywords
- Glioblastoma, Ketogenic diet, Keto diet, GBM
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietOther
A 4-month ketogenic diet will be supervised and monitored by the study investigators. Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining metabolic ketosis.
Standard-of-care radiationRadiation
Patients will receive standard-of-care radiation. Radiation is not protocol directed.
Standard-of-care TemozolomideDrug
Patients will receive standard-of-care temozolomide. Temozolomide is not protocol directed.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet+radiation+temozolomide | Experimental | Ketogenic diet in combination with standard-of-care radiation and standard-of-care temozolomide Receives: Other: Ketogenic Diet; Radiation: Standard-of-care radiation; Drug: Standard-of-care Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the intervention
Proportion of participants experiencing a 10% decrease in weight or body mass index AND have a BMI <18.5 within one month from initiation of the ketogenic diet.
Measured: Four Months
Safety of the intervention
Number of related adverse events based on CTCAE v.5.
Measured: Four months
Secondary outcomes (9)
Feasibility of the intervention
Proportion of enrolled patients able to maintain blood ketone levels >0.3 mM for over 50% of days on study starting 2 weeks after initiation of the ketogenic diet.
Measured: Four Months
Overall Survival
Time (in months) from initiation of the ketogenic diet to date of death
Measured: Sixty months
Time-to-progression
Time (in months) from baseline to progressive disease over study duration (estimated 4 months)
- measured by RANO criteria (standard of care brain MRI)
Measured: Four Months
Quality of Life (two months)
Mean change in overall Quality of Life from baseline to two months.
-Quality of Life measured using EORTC QLQ-C30 global score
Measured: Two months
Quality of Life (four months)
Mean change in overall Quality of Life from baseline to four months.
-Quality of Life measured using EORTC QLQ-C30 global score
Measured: Four months
Cognitive function (Hopkins Verbal Learning Test-Revised)
Mean change in cognitive function from initiation of ketogenic diet to four months.
-measured using Hopkins Verbal learning Test-Revised
Measured: Four months
Cognitive function (Trail Making Test)
Mean change in cognitive function from initiation of ketogenic diet to four months.
-measured using Trail Making Test
Measured: Four months
Cognitive function (Controlled Word Association Test)
Mean change in cognitive function from initiation of ketogenic diet to four months.
-measured using Controlled Word Association Test
Measured: Four months
Cognitive function (Montreal Cognitive Assessment)
Mean change in cognitive function from initiation of ketogenic diet to four months.
-measured using Montreal Cognitive Assessment
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start13 Apr 2018
- Primary completion3 Sep 2021
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBMStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, prospective cohort
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jethro Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jethro Hu, Cedars-Sinai Medical Center
- Investigators
- Jethro Hu, MD, Principal investigator, Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451799
- Sponsor's protocol ID
- IIT2016-17-HU-KETORADTMZ
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2018
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2016-17-HU-KETORADTMZ: A Phase 1 Study of a 4-month Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Newly/Recently Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT03451799
- Acronym / sponsor ID
- IIT2016-17-HU-KETORADTMZ
- Conditions
- GBM, Glioblastoma
- Keywords
- Glioblastoma, Ketogenic diet, Keto diet, GBM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jethro HuUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 2 Mar 2018 (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.
Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining protocol defined metabolic ketosis. Subjects will be monitored for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.
Detailed description
Enrolled subjects will be placed on a 16-week ketogenic diet (subject specific as prescribed by RD) while receiving standard of care cancer treatment (Radiation + Temozolomide). Study dietitians will place patients on a strict and controlled diet that manages daily macronutrient breakdown and increases the ratio of dietary fat relative to protein and carbohydrate consumption. Dietitians will provide guidance and teaching of the diet, as well as, monitoring and diet adjustment to ensure metabolic ketosis. Dietitians and study physicians (and their staff) will monitor subjects for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet+radiation+temozolomide | Experimental | Other: Ketogenic Diet, Radiation: Standard-of-care radiation, Drug: Standard-of-care TemozolomideKetogenic diet in combination with standard-of-care radiation and standard-of-care temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (age ≥ 18 years)
- Newly or recently diagnosed glioblastoma. Patients may enroll in the study from the time of diagnosis (prior to the initiation of standard-of-care chemoradiation) up until the initiation of post-radiation adjuvant chemotherapy (typically approximately 3-4 weeks after the completion of radiation therapy). Overall, this provides a window of approximately 3 months from the time of diagnosis for patients to enroll in this study. No recurrent glioblastoma is allowed on trial.
- Being seen for treatment of glioblastoma at Cedars-Sinai Medical Center. Note: Okay if patients receiving chemotherapy or radiation therapy at another facility
- Patients on low and managed doses of steroids are permitted. Up to 8 mg dexamethasone or steroid equivalent.
Key exclusion criteria (17 listed)
- Karnofsky Performance Status of <70 as deemed by physician or equivalent
- Body Mass Index of <22 kg/m2 (rounded to nearest integer)
- Patients with disorders that affect lipid metabolism such as pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, Beta-Oxidation Defects
- Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
- Pregnant, nursing, or implanted with an intrauterine device (IUD) that is not MR compatible
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 |
|---|---|---|
| Ketogenic DietA 4-month ketogenic diet will be supervised and monitored by the study investigators. Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining metabolic ketosis. | Other | Ketogenic diet+radiation+temozolomide |
| Standard-of-care radiationPatients will receive standard-of-care radiation. Radiation is not protocol directed. | Radiation | Ketogenic diet+radiation+temozolomide |
| Standard-of-care TemozolomidePatients will receive standard-of-care temozolomide. Temozolomide is not protocol directed. | Drug | Ketogenic diet+radiation+temozolomide |
Primary outcome
Safety of the intervention
Time frame: Four Months
Proportion of participants experiencing a 10% decrease in weight or body mass index AND have a BMI <18.5 within one month from initiation of the ketogenic diet.
Safety of the intervention
Time frame: Four months
Number of related adverse events based on CTCAE v.5.
9 secondary outcomes
Feasibility of the intervention
Time frame: Four Months
Overall Survival
Time frame: Sixty months
Time-to-progression
Time frame: Four Months
Quality of Life (two months)
Time frame: Two months
Quality of Life (four months)
Time frame: Four months
Cognitive function (Hopkins Verbal Learning Test-Revised)
Time frame: Four months
Cognitive function (Trail Making Test)
Time frame: Four months
Cognitive function (Controlled Word Association Test)
Time frame: Four months
Cognitive function (Montreal Cognitive Assessment)
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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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. This study is not recruiting at the moment.
Jethro Hu, MD principal investigator
Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketogenic Diet, Standard-of-care radiation and Standard-of-care Temozolomide in people with GBM and Glioblastoma, run by Jethro Hu at 1 site 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the intervention (time frame: Four Months). The study lists 2 primary outcomes in all. 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 15 Apr 2026.