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Completed

NCT Number: NCT01434524

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kochi Medical School

Nankoku, Kochi, 783-8505, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LIVACT

Drug

LIVACT contains 13.0 g of free amino acids

Other names: branched-chain amino acid

Primary outcomes

  1. Postoperative tumor recurrence rate

    Time frame: 5 years follow up

Secondary outcomes

  1. nutritional status

    Time frame: 5 years follow up

    The secondary endpoint was a comparison of measurements of body weight, arm muscle circumference (AMC) between patient groups.

Sponsors and collaborators

Lead sponsor

Kochi University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2011
First posted
Sep 15, 2011
Registry last updated
Sep 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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