UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002330 |
|---|---|
| Receipt number | 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 19:43:25 |
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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
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
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002849
