Status:
ACTIVE_NOT_RECRUITING
Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma
Lead Sponsor:
Jethro Hu
Conditions:
GBM
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03451799
Start Date
April 13 2018
End Date
May 1 2026
Last Update
October 6 2025
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048