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

NCT ID: NCT00945568

Last Updated: 2009-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-06-30

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.

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.

Conditions

Hepatocellular Carcinoma; Chronic Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Aminoleban EN

Intervention Type: DRUG

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

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.

Group Type: NO_INTERVENTION

Aminoleban EN

Intervention Type: DRUG

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

Interventions

Aminoleban EN

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

Intervention Type: DRUG

Other Intervention Names

AEN

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kochi University

OTHER

Sponsor Role: lead

Responsible Party

Kochi University

Principal Investigators

Kazuhiro Hanazaki, Prof

Role: STUDY_DIRECTOR

Kochi University

Locations

Kochi Medical School

Nankoku, Kochi, Japan

Kochi Medical School, Kochi University

Nankoku, Kohasu-Okocho, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 20852905 (View on PubMed)

Other Identifiers

KMS

Identifier Type: -

Identifier Source: secondary_id

AEN-0901

Identifier Type: -

Identifier Source: org_study_id