NCT01535911Active, not recruiting
Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 3 Feb 2012
- Start date
- Apr 2012
- Primary completion date
- Jun 2027
- Lead sponsor
- Michigan State University
- Diseases
- Glioblastoma
- NCT number
- NCT01535911
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From Apr 2012 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of glucocorticosteroids
- Cholecystectomy within 1 year prior to study entry
- 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
Other illness
- Diagnosis of diabetes mellitus that is being treated by medication
- Active malignancy other than primary brain tumor requiring therapy
Other
- Inability to adhere to or tolerate dietary protocol
- Pregnancy
- Inability to give informed consent
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Michigan State University/Sparrow Hospital Coordinator of this site? Confirm its status | East Lansing | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.