NCT00945568

Brief Summary

The aims of this study are (1) to study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery, and (2) To investigate the postoperative quality of life (QOL) in receiving peri-operatively branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic management for hepatocellular carcinoma (HCC) with chronic liver disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started May 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
Last Updated

July 24, 2009

Status Verified

July 1, 2009

Enrollment Period

1.6 years

First QC Date

July 14, 2009

Last Update Submit

July 23, 2009

Conditions

Hepatocellular CarcinomaChronic Liver Disease

Keywords

QOLliver

Outcome Measures

Primary Outcomes (1)

  • To study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery.

    3-6 months

Secondary Outcomes (1)

  • To investigate the safety, rationality and postoperative QOL in receiving peri-operatively branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic management for HCC with chronic liver disease.

    12 months

Study Arms (2)

Aminolaban EN

EXPERIMENTAL

Aminoleban EN™ was administered at a dose of 100 g per day commencing two weeks prior to surgery. A 100 g dose of Aminoleban EN™ contains 13.0 g of free amino acids, 13.0 g of gelatin hydrolysate, 1.0 g of casein, 62.1 g of carbohydrate, 7.0 g of lipid, glycyrrhizin, and other components, producing 420 kcal. The AEN group included 40 patients who were administered 100 g of Aminoleban EN™ as 50 g during the day and 50 g as a late evening snack.

Drug: Aminoleban EN

Control

NO INTERVENTION

The patients were divided into two groups including one group administered Aminoleban (the AEN group) and a control group given no additional dietary supplementation. The total caloric energy intake per day during the study period was assumed to be equal to Aminolaban EN group.

Drug: Aminoleban EN

Interventions

Aminoleban ENDRUG

benefits of this drug for patients who undergoing liver resection for HCC

Also known as: AEN
Aminolaban ENControl

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent elective liver resection for the treatment of hepatocellular carcinoma or adenocarcinoma with chronic liver diseases.

You may not qualify if:

  • Body weight loss greater than 10 per cent during the 6 months prior to surgery,
  • The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kochi Medical School

Nankoku, Kochi, 783-8505, Japan

Location

Kochi Medical School, Kochi University

Nankoku, Kohasu-Okocho, 783-8505, Japan

Location

Related Publications (1)

  • Okabayashi T, Iyoki M, Sugimoto T, Kobayashi M, Hanazaki K. Oral supplementation with carbohydrate- and branched-chain amino acid-enriched nutrients improves postoperative quality of life in patients undergoing hepatic resection. Amino Acids. 2011 Apr;40(4):1213-20. doi: 10.1007/s00726-010-0748-3. Epub 2010 Sep 18.

    PMID: 20852905DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Kazuhiro Hanazaki, Prof

    Kochi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 24, 2009

Study Start

May 1, 2007

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

July 24, 2009

Record last verified: 2009-07

Locations

JP(2)