Preoperative Oral Supplementation With Branched-Chain Amino Acids (BCAA) Improves Postoperative Quality of Life
Information source: Kochi University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatocellular Carcinoma; Chronic Liver Disease
Intervention: Aminoleban EN (Drug)
Phase: N/A
Status: Completed
Sponsored by: Kochi University Official(s) and/or principal investigator(s): Kazuhiro Hanazaki, Prof, Study Director, Affiliation: Kochi University
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: 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.
Secondary outcome: 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.
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Kochi Medical School, Nankoku, Kochi 783-8505, Japan
Kochi Medical School, Kochi University, Nankoku-City, Kohasu-Okocho 783-8505, Japan
Additional Information
Starting date: May 2007
Last updated: July 23, 2009
|