Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

• Status: Terminated
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to see if reducing blood sugar and increasing ketones (a metabolic product that comes from using fats for energy) can increase survival and enhance the the effects of standard radiation and chemotherapy treatments used to treat glioblastoma multiforme (GBM). These changes occur from use of a ketogenic diet. This research has 2 goals:

1. Show that patients can tolerate the diet and maintain low blood glucose and high blood ketone levels.

2. Show if this diet enhances the effectiveness of standard treatment by prolonging survival of patients with a GBM.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• adult patients, 18 - 80 years of age,

• a single enhancing lesion of the brain with MRI appearance consistent with GBM

• Pathologic confirmation of GBM

• Zubrod Performance Scale (ZPS) < 2

• Must be able to undergo MRI imaging with gadolinium

• Must have access to a computer and the internet (to use KetoCalculator© on-line Database)

Exclusion Criteria:

• unable to undergo MRI with gadolinium

• genetic disorders of fat metabolism

• patients receiving sodium valproate (may cause false ketone reading in urine)

• diabetes

• enrolled in another treatment trial for GBM