Ketogenic Diet in Children With Malignant or Recurrent/Refractory Brain Tumor
Stopped early · Not applicable
Conditions studied: Brain Tumors
In brief
The purpose of this study is to evaluate the effect of the ketogenic diet on tumor size and quality of life in pediatric patients with malignant or recurrent/refractory brain tumors.
Key facts
- Study ID
- NCT03328858
- Run by
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- People needed
- 2
- Starts
- 2017-11-01
- Expected to finish
- 2020-01-31
- Last updated by the study team
- 2020-02-05
Who can join
Age: 1 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis Medulloblastoma, high-grade glioma, low-grade glioma, and ependymoma are eligible. Other central nervous system tumors may be considered for treatment at discretion of investigator. Pathology is required unless diffuse intrinsic pontine glioma or optic pathway tumor. The patient should have failed first line therapy and be considered refractory, relapsed, or recurrent. Exceptions are Grade III and Grade IV gliomas including brain stem gliomas who can be enrolled at initial diagnosis.
- Prior Therapy Patients should have already had first line standard of care therapy, unless their initial diagnosis is high grade glioma or DIPG in which case they are eligible. Patients with high grade glioma can be enrolled after the completion of initial radiation. Investigator discretion may also be used.
- Organ Function Requirements A. Functioning gastrointestinal system, i.e. ability to chew and swallow or alternative means of nutrition therapy such as a gastrostomy or jejunostomy tube B. SGPT (ALT) < 3 x upper normal limit; Total Bilirubin ≤ 2 x upper normal limit C. No active pancreatitis D. No arrhythmia or prolonged QT.
You may not qualify if…
- History of cardiac arrhythmia
- Patient unable to chew/swallow and who do not consent to alternative methods of nutrition support, e.g. nasogastric or nasoduodenal tube, or gastrostomy or jejunostomy tube placement.
Where it is running
- Nicklaus Children's Hospital — Miami, Florida, United States
Full record on ClinicalTrials.gov
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