Prevention for the Development of Liver Tumorigenesis by... | NCT01434524

Studies
Prevention for the Development of Liver Tumorigenesis by the Oral Supplementation of Branched-chain Amino Acids

NCT01434524

Sponsor

Kochi University

Status

Completed

Last Update Posted

Sep 15, 2011Estimated

Enrollment

56Actual

Phase

Not Applicable

Conditions

Liver Cancer

Interventions

LIVACT

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
LIVACT 0801	Other Identifier	Kochi Medical School

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Jun 2011Actual

First Submitted Date

Sep 13, 2011

First Submission Date that Met QC Criteria

Sep 14, 2011

First Posted Date

Sep 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2011

Last Update Posted Date

Sep 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The long-term outcomes of branched-chain amino acid (BCAA) administration in patients undergoing hepatic resection remain unclear. The aim of this study is to assess the impact of oral supplementation with BCAA on the prevention for the development of liver tumorigenesis in patients undergoing liver resection.

Detailed Description

This study might demonstrate a tendency of the improvement in the cumulative tumor recurrence rate after hepatectomy for liver neoplasm in the Livact group compared to that in the Control Group. The investigators believe that BCAA seems to be a remarkable benefit for liver resection, especially on its reduction in the recurrence of liver cancer. This treatment regimen has potential to offer benefits for clinical use selectively, especially for patients with chronic liver diseases.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	normal dietary
LIVACT	No Intervention	The present study used LIVACT for preoperative supplementation, commencing two weeks prior to surgery, and continuing for at least 6 months postoperatively with careful monitoring of compliance.	Drug: LIVACT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LIVACT	Drug	LIVACT contains 13.0 g of free amino acids	LIVACT	branched-chain amino acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative tumor recurrence rate		5 years follow up

Secondary Outcomes

Measure	Description	Time Frame
nutritional status	The secondary endpoint was a comparison of measurements of body weight, arm muscle circumference (AMC) between patient groups.	5 years follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

These patients were scheduled for elective liver resection to treat hepatocellular carcinoma or adenocarcinoma of the liver.

Exclusion Criteria:

a body-weight loss greater than 10% during the 6 months prior to surgery,
the presence of distant metastases, or
serious impairment of organ function due to respiratory, renal, or heart disease.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Takehiro Okabayashi, MD	Kochi Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kochi Medical School		Nankoku	Kochi	783-8505	Japan

Type	Date	Date Unknown
Release	Jun 6, 2012
Reset	Jul 10, 2012

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 6, 2012			Jul 10, 2012

Condition Browse Module

MeSH Terms

ID	Term
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000597	Amino Acids, Branched-Chain

Ancestor Terms

ID	Term
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided