Clinical Trial Details
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NCT03451799 : Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- 3.1.1 Adults (age = 18 years)

- 3.1.2 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.

- 3.1.3 Being seen for treatment of GBM at Cedars-Sinai Medical Center

- 3.1.4 Patients on low and managed doses of steroids are permitted. Up to 8 mg
dexamethasone or steroid equivalent.

Exclusion Criteria:

- 3.2.1 Karnofsky Performance Status of <70 as deemed by physician or equivalent

- 3.2.2 Body Mass Index of <24 (rounded to nearest integer)

- 3.2.3 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

- 3.2.4 Pregnancy

- 3.2.5 Patients who are vegan or vegetarian will be excluded, as the ketogenic diet
includes foods that may interfere with these preferences

- 3.2.6 Patients on high doses of steroids will be excluded

- 3.2.7 Inability to adhere to the protocol
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