Could a High-Fat diet help fight brain cancer? early trial tests safety
NCT ID NCT03451799
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tested whether a 4-month ketogenic diet (a high-fat, low-carb diet) is safe and doable for people with newly diagnosed glioblastoma, a serious brain cancer. Twenty-one adults followed personalized meal plans while receiving standard radiation and chemotherapy. The main goals were to check for side effects like severe weight loss and to see if participants could maintain ketosis (a metabolic state). This trial does not yet prove the diet helps treat the cancer, but it aims to lay the groundwork for future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ketogenic diet
- What this could lead to
- If successful, this could show that a ketogenic diet is safe and feasible alongside standard treatment, potentially pointing toward a way to improve outcomes for glioblastoma patients.
- What could go wrong
- This is a very early phase 1 trial with only 21 participants, focused on safety and feasibility, not effectiveness. The diet is demanding and may cause weight loss or other side effects, and it is unclear if it will help fight the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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21 people
The number who actually took part.
- Started
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Apr 2018
- Finished
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Apr 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
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