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KMS: Preoperative Oral Supplementation With Branched-Chain Amino Acids (BCAA) Improves Postoperative Quality of Life

Sponsor
Kochi University (Other)
Overall Status
Completed
CT.gov ID
NCT00945568
Collaborator
(none)
100
Enrollment
2
Locations
2
Arms
25
Duration (Months)
50
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aminoleban EN
 N/A

Detailed Description

Patients with cirrhosis of the liver complicated with HCC are often in a state of protein energy malnutrition. A limited number of studies have indicated an important role for nutritional support in the surgical management of patients who have undergone hepatic resection for HCC. In a preliminary study, we reported the clinical efficacy of supplementation with branched-chain amino acids in a small number of patients with liver cirrhosis who underwent hepatic surgery for HCC. 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 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Preoperative Oral Supplementation With Carbohydrate and Branched-chain Amino Acid-enriched Nutrient Improves Postoperative Quality of Life in Patients Undergoing a Hepatectomy
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aminolaban EN

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
benefits of this drug for patients who undergoing liver resection for HCC
Other Names:
  • AEN

    		•
    No Intervention: Control

    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
    benefits of this drug for patients who undergoing liver resection for HCC
    Other Names:
  • AEN

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who underwent elective liver resection for the treatment of hepatocellular carcinoma or adenocarcinoma with chronic liver diseases.
    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kochi Medical School Nankoku Kochi Japan 783-8505
    2 Kochi Medical School, Kochi University Nankoku-City Kohasu-Okocho Japan 783-8505

    Sponsors and Collaborators

    • Kochi University

    Investigators

    • Study Director: Kazuhiro Hanazaki, Prof, Kochi University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00945568
    Other Study ID Numbers:
    • AEN-0901
    • KMS
    First Posted:
    Jul 24, 2009
    Last Update Posted:
    Jul 24, 2009
    Last Verified:
    Jul 1, 2009
    Keywords provided by , ,
    QOL
    liver
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Jul 24, 2009