Overview

Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma

Status:
Active, not recruiting
Trial end date:
2023-10-01
Target enrollment:
0
Participant gender:
All
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 ketosis. Subjects will be monitored for safety, nutrition, quality of life, and standard of care tumor assessments over the course of the study.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jethro Hu
Treatments:
Dacarbazine
Temozolomide
Criteria
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.