Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors
Running, not enrolling · Not applicable
Conditions studied: Glioblastoma
In brief
This study will look at the effects, good and/or bad, of treating primary brain cancers with diet therapy using an energy restricted ketogenic diet (ERKD) that uses food. An energy restricted ketogenic diet is a diet designed to keep blood sugars in the low range of normal while at the same time increasing the blood concentration of metabolic break down products called ketones. This diet is currently used to treat children with uncontrollable seizures. This diet is well tolerated by the children with minimal side effects reported after using the diet for years. * The main purpose of this study is to find out whether or not the energy restricted ketogenic diet will help patients with primary brain cancer by either decreasing the size of the cancer or by keeping the cancer from growing. * Another reason for doing this study is to learn about the side effects associated with the energy restricted ketogenic diet in patients with primary brain cancer.
Key facts
- Study ID
- NCT01535911
- Run by
- Michigan State University
- People needed
- 16
- Starts
- 2012-04-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-02-05
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Diagnosis of diabetes mellitus that is being treated by medication
- Concomitant use of glucocorticosteroids
- Cholecystectomy within 1 year prior to study entry
- Inability to adhere to or tolerate dietary protocol
- Active malignancy other than primary brain tumor requiring therapy
- Participation in an investigational study within 2 weeks prior to study entry; Major co-morbidities such as liver, kidney or heart failure that in the judgment of the investigators would disqualify the subject from the trial
- Pregnancy
- Inability to give informed consent
Where it is running
- Michigan State University/Sparrow Hospital — East Lansing, Michigan, United States
Full record on ClinicalTrials.gov
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