UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001255
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Department of Gastroenterology and Hepatology, Yamaguchi Univercity Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001517

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.