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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01434524
Recruitment Status : Completed
First Posted : September 15, 2011
Last Update Posted : September 15, 2011
Information provided by (Responsible Party):
Takehiro Okabayashi, 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.

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: LIVACT Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
normal dietary
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

Primary Outcome Measures :
  1. Postoperative tumor recurrence rate [ Time Frame: 5 years follow up ]

Secondary Outcome Measures :
  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.

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01434524

Kochi Medical School
Nankoku, Kochi, Japan, 783-8505
Sponsors and Collaborators
Kochi University
Principal Investigator: Takehiro Okabayashi, MD Kochi Medical School

Responsible Party: Takehiro Okabayashi, Kochi Medical School, Kochi University Identifier: NCT01434524     History of Changes
Other Study ID Numbers: LIVACT 0801
LIVACT 0801 ( Other Identifier: Kochi Medical School )
First Posted: September 15, 2011    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Liver Neoplasms
Cell Transformation, Neoplastic
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes