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

The Evaluation About the 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.

Study Overview

• Status: Completed
• Conditions: Liver Cancer
• Intervention / Treatment: Drug: LIVACT

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
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Kochi
    • Nankoku, Kochi, Japan, 783-8505
      • Kochi Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Drug: LIVACT; LIVACT contains 13.0 g of free amino acids; Other Names: branched-chain amino acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative tumor recurrence rate	5 years follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nutritional status	The secondary endpoint was a comparison of measurements of body weight, arm muscle circumference (AMC) between patient groups.	5 years follow up

Collaborators and Investigators

• Sponsor: Kochi University
• Investigators: Principal Investigator: Takehiro Okabayashi, MD, Kochi Medical School

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 14, 2011
• First Posted (Estimate): September 15, 2011

Study Record Updates

• Last Update Posted (Estimate): September 15, 2011
• Last Update Submitted That Met QC Criteria: September 14, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Carcinogenesis; Cell Transformation, Neoplastic
• Other Study ID Numbers: LIVACT 0801 (Other Identifier: Kochi Medical School)