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

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