UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001255 |
|---|---|
| Receipt number | R000001517 |
| Scientific Title | The investigation for the improvement of nutrition using a branched-chain amino acid (BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with hepatocellular carcinoma |
| Date of disclosure of the study information | 2008/07/22 |
| Last modified on | 2015/01/28 17:39:58 |
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Basic information
Public title
The investigation for the improvement of nutrition using a branched-chain amino acid
(BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with hepatocellular carcinoma
Acronym
The investigation for the improvement of nutrition using a branched-chain amino acid
(BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with hepatocellular carcinoma
Scientific Title
The investigation for the improvement of nutrition using a branched-chain amino acid
(BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with hepatocellular carcinoma
Scientific Title:Acronym
The investigation for the improvement of nutrition using a branched-chain amino acid
(BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Liver cirrhosis associated with hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this randomized control study is to compare the efficacy and safety of a branched-chain amino acid (BCAA)-enriched nutrient with that of diet alone for advanced hepatocellular carcinoma recieving hepatic arterial infusion chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
occurence of the following events: ascites, peripheral edema, bleeding of gastrointerstinal tract, hepatic encephalopathy, others
Key secondary outcomes
SF-36
nutrition status using an indirect calorimeter(RQ)
reserved liver function(Alb)
BTR
Change of blood cell count(WBC, RBC, lymphocyte, Plt)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diet group: Diet therapy alone (30-35kcal/kg/day) during treatments and follow up periods
Interventions/Control_2
Aminoreban EN group: Oral supplementation with two pack of Aminoreban EN (one pack during a day, ie at sometime from 10 a.m. to 3 p.m. and other pack at 10 p.m. as late evening snack (LES)) during treatments and follow up periods
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Hepatocellular carcinoma recieving hepatic arterial infusion chemotherapy
2. Virgin case of hepatic arterial infusion chemotherapy
3. Not relate to pervious treatment for hepatocellular carcinoma
4. Need to administration of hepatic arterial infusion chemotherapy
5. WBC>=3,000/mm3
6. Plt>=50,000/ul
7. Age is more 20 years old and less or equal 80 years old, male and female
8. Need to wash out period for one week, for patients who peviously administerd Aminoreban EN or another BCAA-enriched nutrient
Key exclusion criteria
1. Extrahepatic metastasis
2. History of anaphylactic reaction for amino acid nutrient
3. Severe renal dysfunction
4. Congenital amino-acid metabolism abnormality
5. Milk allergy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Sakaida |
Organization
Yamaguchi Univercity Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Minamikoguchi, Ube, Yamaguchi, 755-8505, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Yamasaki |
Organization
Yamaguchi Univercity Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 Minamikoguchi, Ube, Yamaguchi, 755-8505, Japan
TEL
0836-22-2239
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Yamaguchi Univercity Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2008 | Year | 07 | Month | 22 | 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
| 2008 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | 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
| 2008 | Year | 07 | Month | 18 | Day |
Last modified on
| 2015 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001517
