Unique ID issued by UMIN | UMIN000031308 |
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Receipt number | R000033955 |
Scientific Title | Pilot study of ketogenic diet adjunctive to standard therapy for malignant glioma. |
Date of disclosure of the study information | 2018/04/01 |
Last modified on | 2024/02/22 08:33:32 |
Pilot study of ketogenic diet adjunctive to standard therapy for malignant glioma.
Ketogenic diet therapy for malignant glioma.
Pilot study of ketogenic diet adjunctive to standard therapy for malignant glioma.
Ketogenic diet therapy for malignant glioma.
Japan |
malignant glioma
Neurosurgery |
Malignancy
NO
The goal of the present study is to evaluate safety, feasibility and tolerability of ketogenic diet administered adjunctively to standard radio-chemotherapy in patients with newly or recurrent malignant glioma.
Others
Malignant glioma is the commonest form of brain cancer in adults. Despite current treatment options including surgery, radiotherapy and chemotherapy, overall survival is poor. Therefore, other treatment options are being explored. The ketogenic diet is a high fat, low carbohydrate diet. This encourages the body to use fat (broken down to ketones) as its primary energy source, instead of carbohydrate. Ketogenic diet have been considered for use in patients with glioma as this type of cancer is thought to use glucose as its main energy supply. Animal studies have shown ketogenic diet may make glioma more responsive to radiotherapy and chemotherapy and could improve survival by slowing the tumor's growth. However, clinical studies are needed in humans to assess any possible benefits. The aim of the trial is to investigate safety, protocol feasibility and tolerability for the patient with malignant glioma, with a view to informing future phase II clinical trials.
Exploratory
Pragmatic
Not applicable
Duration of ketogenic diet therapy
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
1
Treatment
Food |
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 starting ketogenic diet: Daily carbohydrate intake 30g or less
Total energy:40kcal/kg/day
Protein:1g/kg/day
(*The ketone ratio can be adjusted appropriately using medium chain fatty acid oil)
20 | years-old | <= |
Not applicable |
Male and Female
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 %
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
10
1st name | Takashi |
Middle name | |
Last name | Sasayama |
Kobe University Hospital
Neurosurgery
650-0017
Kusunoki-Cho 7-5-2 Chuou-ku
0783825966
takasasa@med.kobe-u.ac.jp
1st name | Kazuhiro |
Middle name | |
Last name | Tanaka |
Kobe University Hospital
Neurosurgery
6500017
Kusunoki-Cho 7-5-2 Chuou-ku
0783825966
kazutana@med.kobe-u.ac.jp
Kobe University Hospital
Takashi Sasayama
Grants-in-Aid for Scientific Research (KAKENHI)
Japanese Governmental office
Osaka University
KOBE Univ. Hosp. Clinical and Translational Research Center
7-5-2 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo prefecture
0783825111
cerb@med.kobe-u.ac.jp
NO
2018 | Year | 04 | Month | 01 | Day |
Unpublished
Open public recruiting
2017 | Year | 11 | Month | 14 | Day |
2018 | Year | 07 | Month | 17 | Day |
2020 | Year | 01 | Month | 10 | Day |
2024 | Year | 03 | Month | 31 | Day |
2018 | Year | 02 | Month | 14 | Day |
2024 | Year | 02 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033955
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