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 :
Active, not recruiting
First Posted : February 20, 2012
Last Update Posted : May 2, 2022
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors |
Actual Study Start Date : | April 1, 2012 |
Estimated Primary Completion Date : | June 1, 2024 |
Estimated Study Completion Date : | June 1, 2024 |

- 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.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kenneth Schwartz, MD, Professor, Michigan State University |
ClinicalTrials.gov Identifier: | NCT01535911 |
Other Study ID Numbers: |
11-452FS |
First Posted: | February 20, 2012 Key Record Dates |
Last Update Posted: | May 2, 2022 |
Last Verified: | April 2022 |
ketogenic diet brain tumors |
Glioblastoma Brain Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |