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NCT01434524 Clinical Trial

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

Liver Cancer Clinical Trial

Official title:
The Evaluation About the Prevention for the Development of Liver Tumorigenesis by the Oral Supplementation of Branched-chain Amino Acids

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01434524
Other study ID # LIVACT 0801
Secondary ID LIVACT 0801
Status Completed
Phase N/A
First received September 13, 2011
Last updated September 14, 2011
Start date April 2007
Est. completion date June 2011

Study information
Verified date September 2011
Source Kochi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date June 2011
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 90 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LIVACT
LIVACT contains 13.0 g of free amino acids

Locations
Country Name City State
Japan Kochi Medical School Nankoku Kochi

Sponsors (1)
Lead Sponsor Collaborator
Kochi University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative tumor recurrence rate 5 years follow up
Secondary nutritional status The secondary endpoint was a comparison of measurements of body weight, arm muscle circumference (AMC) between patient groups. 5 years follow up
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