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
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma Chronic Liver Disease | Drug: Aminoleban EN | Not Applicable |
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 |

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.
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Drug: Aminoleban EN
benefits of this drug for patients who undergoing liver resection for HCC
Other Name: AEN
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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.
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Drug: Aminoleban EN
benefits of this drug for patients who undergoing liver resection for HCC
Other Name: AEN
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- 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 ]
- 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 ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
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.

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
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 |
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 |