Preoperative Oral Supplementation With Branched-Chain Amino Acids (BCAA) Improves Postoperative Quality of Life (KMS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00945568
| Japan | |
| Kochi Medical School | |
| Nankoku, Kochi, Japan, 783-8505 | |
| Kochi Medical School, Kochi University | |
| Nankoku-City, Kohasu-Okocho, Japan, 783-8505 | |
| 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, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases |
Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on March 03, 2015