Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors (Ketones)
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|ClinicalTrials.gov Identifier: NCT01535911|
Recruitment Status : Recruiting
First Posted : February 20, 2012
Last Update Posted : July 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Other: Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Other: Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy)
- MRI imaging will be used to measure changes in brain tumor size. [ Time Frame: 6 weeks after completion of radiation therapy ]Results of the metabolic therapy will be assessed by comparing MRI images obtained at the beginning of the study with those after completion of radiation therapy and after an additional 6 weeks of metabolic therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535911
|Contact: Kenneth Schwartz, MD||517-975-9547|
|United States, Michigan|
|Michigan State University/Sparrow Hospital||Recruiting|
|East Lansing, Michigan, United States, 48824|
|Contact: Ken A. Schwartz, MD 517-353-4811 firstname.lastname@example.org|
|Contact: Mary M. Noel, PhD 517.884.0451 email@example.com|
|Principal Investigator: Ken A Schwartz, MD|
|Principal Investigator:||Kenneth Schwartz, MD||Michigan State University|