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NCT01535911 · ClinicalTrials.gov registry record · NA
Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors
A NA study of Glioblastoma, sponsored by Michigan State University.
- Active
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01535911: Active NA study of Glioblastoma, sponsored by Michigan State University.
NCT01535911 is a NA study of Glioblastoma that is active but no longer recruiting, run by Michigan State University. The registered enrollment target is 16 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01535911, a NA study of Glioblastoma, is active but no longer recruiting, sponsored by Michigan State University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy)
Study Locations (1)
Michigan
- Michigan State University/Sparrow Hospital - East Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-04-01 |
| Est. Completion | 2027-06-01 |
| Phase | NA |
What the registry record for NCT01535911 still lists
NCT01535911 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy) is the first listed.
NCT01535911 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01535911 about?
NCT01535911 is a clinical study titled "Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors". 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 inc...
What is the current status of trial NCT01535911?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 16 participants. The study started on 2012-04-01. Estimated completion is 2027-06-01.
What conditions does trial NCT01535911 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT01535911?
The interventions under investigation include: Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy) (OTHER).
Who is sponsoring clinical trial NCT01535911?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01535911 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01535911's enrollment target sits among peer trials
16 170th of 199 higher than 29 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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