Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors (Ketones)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01535911|
Recruitment Status : Active, not recruiting
First Posted : February 20, 2012
Last Update Posted : October 31, 2018
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)|
|Actual Enrollment :||16 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 :||October 31, 2018|
|Estimated Study Completion Date :||June 2019|
- Other: Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy)
Adult subjects with newly diagnosed glioblastoma will be referred to the study. Residual tumor size will be determined using MRI imaging. Subjects will be placed on ERKD while they are being treated with radiation therapy and standard of care chemotherapy. After completion of radiation therapy, tumor size will be determined using MRI. If the tumor has decreased in size or remained the same (stable disease), the subjects will be continued on the ERKD for an additional 6 weeks. Total calories consumed by each subject will be targeted to 20 to 25 kcal/kg/day. If the tumor has decreased in size or the size has remained the same then subjects will be continued on the ERKD for as additional 6 weeks and a repeat MRI will be obtained.Other Name: Ketogenic diet
- 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
|United States, Michigan|
|Michigan State University/Sparrow Hospital|
|East Lansing, Michigan, United States, 48824|
|Principal Investigator:||Kenneth Schwartz, MD||Michigan State University|