Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

Stopped early · Phase 1/Phase 2

Conditions studied: Glioblastoma (GBM)

In brief

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.

Key facts

Study ID

NCT02046187

Run by

St. Joseph's Hospital and Medical Center, Phoenix

People needed

14

Starts

2013-10-01

Expected to finish

2017-02-01

Last updated by the study team

2021-06-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute at St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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