Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
This study is being done to see if a Ketogenic Diet (KD) or short-term Ketone supplement (KS) is feasible and safe for patients with recurrent Glioma who are undergoing a clinically indicated surgery.
The primary objective of the study is to determine the feasibility and safety of short-term ketone supplementation or a ketogenic diet in patients with recurrent glioma for seven days prior to surgery. The secondary objective of the study is to assess the physiologic effects of a 7-day ketone supplementation or ketogenic diet on tumor and systemic metabolism as measured by ketones (BHB and ACE) on MR spectroscopy (MRS) and blood ketone levels (hours per 24 where BHB \> 0.9 mM).
Inclusion Criteria: * Histopathologic diagnosis of a glioma that has received prior irradiation and is presumed recurrent. * Clinical indication for open biopsy or surgical resection. * On MRI, a 2x2x2 cm enhancement absent of bleed, calcification, or other features that can obscure MRS signal. * Karnofsky performance status ≥ 70. * Age \> 18 years. * Willing to submit archival tumor sample if available. * Patients must have the following organ and marrow function: * Absolute neutrophil count \>1,000/mcL * Total bilirubin \< 1.5 x institutional upper limit of normal (ULN) OR total bilirubin \…
Arm 1 will use Ketone supplement 80 gm daily
Arm 2 participants will follow a 2.5:1 - 3:1 ketogenic diet (KD) daily for 7 days leading up to the clinically indicated surgery.
Arctuva estimate
Verify or correct the compensation shown for this listing.