UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031308
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

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Basic information

Public title

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

Acronym

Ketogenic diet therapy for malignant glioma.

Scientific Title

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

Scientific Title:Acronym

Ketogenic diet therapy for malignant glioma.

Region

Japan


Condition

Condition

malignant glioma

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Others

Basic objectives -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.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Duration of ketogenic diet therapy

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

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)

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key 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 %

Key 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

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Sasayama

Organization

Kobe University Hospital

Division name

Neurosurgery

Zip code

650-0017

Address

Kusunoki-Cho 7-5-2 Chuou-ku

TEL

0783825966

Email

takasasa@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Kazuhiro
Middle name
Last name Tanaka

Organization

Kobe University Hospital

Division name

Neurosurgery

Zip code

6500017

Address

Kusunoki-Cho 7-5-2 Chuou-ku

TEL

0783825966

Homepage URL


Email

kazutana@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Hospital

Institute

Department

Personal name

Takashi Sasayama


Funding Source

Organization

Grants-in-Aid for Scientific Research (KAKENHI)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Osaka University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

KOBE Univ. Hosp. Clinical and Translational Research Center

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo prefecture

Tel

0783825111

Email

cerb@med.kobe-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2017 Year 11 Month 14 Day

Date of IRB

2018 Year 07 Month 17 Day

Anticipated trial start date

2020 Year 01 Month 10 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 14 Day

Last modified on

2024 Year 02 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033955


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name