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