Prevention for the Development of Liver Tumorigenesis by the Oral Supplementation of Branched-chain Amino Acids
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Evaluation About the Prevention for the Development of Liver Tumorigenesis by the Oral Supplementation of Branched-chain Amino Acids|
- Postoperative tumor recurrence rate [ Time Frame: 5 years follow up ] [ Designated as safety issue: Yes ]
- nutritional status [ Time Frame: 5 years follow up ] [ Designated as safety issue: Yes ]The secondary endpoint was a comparison of measurements of body weight, arm muscle circumference (AMC) between patient groups.
|Study Start Date:||April 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
No Intervention: Control
No Intervention: 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.
LIVACT contains 13.0 g of free amino acids
Other Name: branched-chain amino acid
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434524
|Kochi Medical School|
|Nankoku, Kochi, Japan, 783-8505|
|Principal Investigator:||Takehiro Okabayashi, MD||Kochi Medical School|