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

* 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 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


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

Value
https://center6.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