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

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ClinicalTrials.gov Identifier: NCT00945568
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : July 24, 2009
Sponsor:
Information provided by:
Kochi University

Study Description
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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
Hepatocellular Carcinoma Chronic Liver Disease Drug: Aminoleban EN Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Arms and Interventions
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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 Name: 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 Name: AEN


Outcome Measures
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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. [ Time Frame: 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. [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945568


Locations
Japan
Kochi Medical School
Nankoku, Kochi, Japan, 783-8505
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kochi Medical School, Kochi University
ClinicalTrials.gov Identifier: NCT00945568     History of Changes
Other Study ID Numbers: AEN-0901
KMS
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: July 24, 2009
Last Verified: July 2009

Keywords provided by Kochi University:
QOL
liver

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases