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

Kochi University

Status: Completed

Conditions: Chronic Liver Disease; Hepatocellular Carcinoma

Treatments: Drug: Aminoleban EN

Study type: Interventional

Funder types: Other

Identifiers

NCT00945568

AEN-0901

KMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Aminolaban EN

Experimental group

Description:

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.

Treatment:

Drug: Aminoleban EN

Control

No Intervention group

Description:

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.

Treatment:

Drug: Aminoleban EN