Pilot study of ketogenic diet adjunctive to standard therapy for malignant glioma.
- Conditions
- malignant glioma
- Registration Number
- JPRN-UMIN000031308
- Lead Sponsor
- Kobe University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Not provided
1. Age <20-year-old 2. Gastrointestinal obstruction or ileus 3. HbA1c > 6.1 %, or medication of DM 4. Inability of ketone body production from fatty acid 5. Genetic disorders of fat metabolism (Organic cation transporter 2 (OCTN2) deficiency, Carnitine palmitoyl transferase I or II deficiency, Carnitine palmitoyl transferase II deficiency, beta-oxidation enzyme deficiency, Medium-chain acyl-CoA dehydrogenase (MCAD) deficiency, Long-chain acyl-CoA dehydrogenase (MCAD) deficiency, Short-chain acyl-CoA dehydrogenase (MCAD) deficiency, 3-hydroxy acyl-CoA dehydrogenase (HADH) deficiency, Pyruvate carboxylase deficiency) 6. Heart failure (NYHA >2), acute myocardil infarction (<=6 months), atrial fibrillation 7. Systemic infection 8. Enrolled in another treatment trial 9. Inability or unwillingness of subject to give written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of ketogenic diet therapy
- Secondary Outcome Measures
Name Time Method 1) 1 year survival rate 2) Overall survival 3) Progression-free survival time 4) Tumor shrinkage rate 5) Changes in blood ketone body levels during ketogenic diet therapy 6) Changes in intratumoral metabolites measured by MR spectroscopy before and after ketogenic diet therapy 7) Rate of adverse event occurrence 8) Reasons why the patient could not continue the ketogenic diet
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