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

Not Applicable

Completed

• Conditions: Liver Cancer
• Interventions: Drug: LIVACT

• Registration Number: NCT01434524
• Lead Sponsor: Kochi University

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.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2008-10
• Study Completion: 2011-06
• Status Verified: 2011-09
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-14
• Last Update Submitted: 2011-09-14
• Study First Posted: 2011-09-15
• Last Update Posted: 2011-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LIVACT	LIVACT	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.

Primary Outcome Measures

Name	Time	Method
Postoperative tumor recurrence rate	5 years follow up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kochi Medical School; 🇯🇵 Nankoku, Kochi, Japan