Pilot study of ketogenic diet adjunctive to standard therapy for malignant glioma.

Pilot study of ketogenic diet adjunctive to standard therapy for malignant glioma. - Ketogenic diet therapy for malignant glioma.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031308

Enrollment

Registered

2018-04-01

Start date

2020-01-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant glioma

Interventions

Ketogenic diet 1st week of starting ketogenic diet: Daily carbohydrate intake 10g or less 2nd week to 2 months of starting ketogenic diet: Daily carbohydrate intake 20g or less After 3rd month of s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >= 20-year-old 2. Diagnosed with malignant glioma (WHO grade 3~4 glioma) 3. Measureable tumor in MRI 4. KPS>=50 5. Creatinine <= 1.5 mg/dl, Uric acid <= 50 mg/dl, PT INR <= 1.5, AST (GOT) <=7 x normal maximum ALT (GPT) <= 7 xnormal maximum HbA1c <= 6.1 %

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Duration of ketogenic diet therapy	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactKazuhiro Tanaka

Kobe University Hospital Neurosurgery

kazutana@med.kobe-u.ac.jp0783825966

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026