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

Information source: Kochi University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Cancer

Intervention: LIVACT (Drug)

Phase: N/A

Status: Completed

Sponsored by: Kochi University

Official(s) and/or principal investigator(s):
Takehiro Okabayashi, MD, Principal Investigator, Affiliation: Kochi Medical School


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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Postoperative tumor recurrence rate

Secondary outcome: nutritional status

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.


Minimum age: 16 Years. Maximum age: 90 Years. Gender(s): Both.


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.

Locations and Contacts

Kochi Medical School, Nankoku, Kochi 783-8505, Japan
Additional Information

Starting date: April 2007
Last updated: September 14, 2011

Page last updated: August 23, 2015

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