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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002330
Receipt No. R000002849
Scientific Title Japanease multi-center clinical trial to assess the inhibitory effects of branched chain amino acids on the recurrence after curative treatment of hepatocellular carcinoma
Date of disclosure of the study information 2009/08/12
Last modified on 2012/02/15

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Basic information
Public title Japanease multi-center clinical trial to assess the inhibitory effects of branched chain amino acids on the recurrence after curative treatment of hepatocellular carcinoma
Acronym HCC prevention study by BCAA
Scientific Title Japanease multi-center clinical trial to assess the inhibitory effects of branched chain amino acids on the recurrence after curative treatment of hepatocellular carcinoma
Scientific Title:Acronym HCC prevention study by BCAA
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the inhibitory effects of branched chain amino acids on the recurrence after curative treatment of hepatocellular carcinoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Time to recurrence of hepatocellular carcinoma
Key secondary outcomes Survival time,
Change of hepatic reserve,
Change of lipid metabolisum and glucose tolerance,
Change of nutritional state, etc

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diet therapy group
Interventions/Control_2 Diet + BCAA therapy group
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 The following HCC patients who are curatively treated with resection or RFA.
1.20 years of age and older.
2.HCV RNA positive liver cirrhosis and 2.8-4.0 g/dl in serum albumin level.
3.New-onset HCC (no extrahepatic lesion, no more than 3lesions and the largest measuring 3cm and below).
4.Clinical diagnosis with imaging tests and tumor markers, add to pathological findings in impossible cases.
5.Comfirmation of no recurrence with CE-CT or CE-US, MRI at a month after treatment.
Key exclusion criteria 1.Impregnated patient
2.Complication of ascites, edema and hepatic coma
3.Intrahepatic cholangiocarcinoma and metastatic liver tumor
4.Patient who is difficult to keep a diet therapy going
5.Insulin-treated diabetic patient
6.HCV negative patient after interferon therapy
7.HBsAg positive patient, heavy user of alcohol (more than 60g/day/ ethanol)
8.Patient who is in treatment with antiviral drug (Interferon, Peg-interforon, Ribavirin, etc)
9.Patient who is complicated with renal dysfunction including dialysis.
10.Patient who is associated with heavy heart, lung and hematological disorder, or others.
11.Inegible patient at a physician's discretion
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Suzuki
Organization Iwate Medical University, School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address Uchimaru, Morioka, Iwate, 020-8505, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Iwate Medical University, School of Medicine
Division name Division of Gastroenterology and Hepatology,Department of Internal Medicine
Zip code
Address Uchimaru, Morioka, Iwate, 020-8505, Japan
TEL
Homepage URL
Email

Sponsor
Institute Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization Research grant from tha Japanease Ministry of health, Labour and Walfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 08 Month 12 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 Terminated
Date of protocol fixation
2009 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 12 Day
Last modified on
2012 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002849

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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