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

This study has been completed.
Sponsor:
Information provided by:
Kochi University
ClinicalTrials.gov Identifier:
NCT00945568
First received: July 14, 2009
Last updated: July 23, 2009
Last verified: July 2009
  Purpose

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 Intervention
Hepatocellular Carcinoma
Chronic Liver Disease
Drug: Aminoleban EN

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kochi University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: May 2007
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Kochi University

Additional 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
Study First Received: July 14, 2009
Last Updated: July 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Kochi University:
QOL
liver

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

ClinicalTrials.gov processed this record on August 28, 2014