Back to results

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

Primary Purpose

Liver Cancer

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

LIVACT

About this trial

This is an interventional prevention trial for Liver Cancer

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kochi Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Arm Label

Control

LIVACT

Arm Description

normal dietary

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.

Outcomes

Primary Outcome Measures

Postoperative tumor recurrence rate

Secondary Outcome Measures

nutritional status

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

Full Information

NCT ID

NCT01434524

First Posted

September 13, 2011

Last Updated

September 14, 2011

Sponsor

Kochi University

1. Study Identification

Unique Protocol Identification Number

NCT01434524

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kochi University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

normal dietary

Arm Title

LIVACT

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

LIVACT

Other Intervention Name(s)

branched-chain amino acid

Intervention Description

LIVACT contains 13.0 g of free amino acids

Primary Outcome Measure Information:

Title

Postoperative tumor recurrence rate

Time Frame

5 years follow up

Secondary Outcome Measure Information:

Title

nutritional status

Description

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

Time Frame

5 years follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Takehiro Okabayashi, MD

Organizational Affiliation

Kochi Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kochi Medical School

City

Nankoku

State/Province

Kochi

ZIP/Postal Code

783-8505

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs