Glioblastoma Clinical Trial
— KetonesOfficial title:
Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors
Verified date | April 2024 |
Source | Michigan State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 16 |
Est. completion date | June 1, 2026 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | - Inclusion Criteria: - Adult subjects over age 18 with biopsy proven GBM diagnosis - Measurable disease after standard therapies - Eastern Cancer Oncology Group performance status < or =2; and - Life expectancy >3 months. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Michigan State University/Sparrow Hospital | East Lansing | Michigan |
Lead Sponsor | Collaborator |
---|---|
Michigan State University | Sparrow Health System |
United States,
Seyfried TN, Marsh J, Shelton LM, Huysentruyt LC, Mukherjee P. Is the restricted ketogenic diet a viable alternative to the standard of care for managing malignant brain cancer? Epilepsy Res. 2012 Jul;100(3):310-26. doi: 10.1016/j.eplepsyres.2011.06.017. Epub 2011 Aug 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRI imaging will be used to measure changes in brain tumor size. | 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. | 6 weeks after completion of radiation therapy |
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