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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takehiro Okabayashi, Kochi University
ClinicalTrials.gov Identifier:
NCT01434524
First received: September 13, 2011
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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 Intervention
Liver Cancer
Drug: LIVACT

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Kochi University:

Primary Outcome Measures:
  • Postoperative tumor recurrence rate [ Time Frame: 5 years follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.


Enrollment: 56
Study Start Date: April 2007
Study Completion Date: June 2011
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: LIVACT
LIVACT contains 13.0 g of free amino acids
Other Name: branched-chain amino acid

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

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434524

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

No publications provided

Responsible Party: Takehiro Okabayashi, Kochi Medical School, Kochi University
ClinicalTrials.gov Identifier: NCT01434524     History of Changes
Other Study ID Numbers: LIVACT 0801, LIVACT 0801
Study First Received: September 13, 2011
Last Updated: September 14, 2011
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

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

ClinicalTrials.gov processed this record on April 22, 2014