NCT01434524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2011

Completed
Last Updated

September 15, 2011

Status Verified

September 1, 2011

Enrollment Period

1.5 years

First QC Date

September 13, 2011

Last Update Submit

September 14, 2011

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Postoperative tumor recurrence rate

    5 years follow up

Secondary Outcomes (1)

  • nutritional status

    5 years follow up

Study Arms (2)

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

LIVACTDRUG

LIVACT contains 13.0 g of free amino acids

Also known as: branched-chain amino acid
LIVACT

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kochi Medical School

Nankoku, Kochi, 783-8505, Japan

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Amino Acids, Branched-Chain

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Takehiro Okabayashi, MD

    Kochi Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kochi Medical School

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 15, 2011

Study Start

April 1, 2007

Primary Completion

October 1, 2008

Study Completion

June 1, 2011

Last Updated

September 15, 2011

Record last verified: 2011-09

Locations

JP(1)