Prevention for the Development of Liver Tumorigenesis by the Oral Supplementation of Branched-chain Amino Acids
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Purpose
The long-term outcomes of branched-chain amino acid (BCAA) administration in patients undergoing hepatic resection remain unclear. The aim of this study is to assess the impact of oral supplementation with BCAA on the prevention for the development of liver tumorigenesis in patients undergoing liver resection.
| Condition | Intervention |
|---|---|
|
Liver Cancer |
Drug: LIVACT |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Evaluation About the Prevention for the Development of Liver Tumorigenesis by the Oral Supplementation of Branched-chain Amino Acids |
- Postoperative tumor recurrence rate [ Time Frame: 5 years follow up ] [ Designated as safety issue: Yes ]
- nutritional status [ Time Frame: 5 years follow up ] [ Designated as safety issue: Yes ]The secondary endpoint was a comparison of measurements of body weight, arm muscle circumference (AMC) between patient groups.
| Enrollment: | 56 |
| Study Start Date: | April 2007 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
normal dietary
|
|
|
No Intervention: LIVACT
The present study used LIVACT for preoperative supplementation, commencing two weeks prior to surgery, and continuing for at least 6 months postoperatively with careful monitoring of compliance.
|
Drug: LIVACT
LIVACT contains 13.0 g of free amino acids
Other Name: branched-chain amino acid
|
Detailed Description:
This study might demonstrate a tendency of the improvement in the cumulative tumor recurrence rate after hepatectomy for liver neoplasm in the Livact group compared to that in the Control Group. The investigators believe that BCAA seems to be a remarkable benefit for liver resection, especially on its reduction in the recurrence of liver cancer. This treatment regimen has potential to offer benefits for clinical use selectively, especially for patients with chronic liver diseases.
Eligibility| Ages Eligible for Study: | 16 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- These patients were scheduled for elective liver resection to treat hepatocellular carcinoma or adenocarcinoma of the liver.
Exclusion Criteria:
- a body-weight loss greater than 10% during the 6 months prior to surgery,
- the presence of distant metastases, or
- serious impairment of organ function due to respiratory, renal, or heart disease.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Takehiro Okabayashi, Kochi Medical School, Kochi University |
| ClinicalTrials.gov Identifier: | NCT01434524 History of Changes |
| Other Study ID Numbers: | LIVACT 0801, LIVACT 0801 |
| Study First Received: | September 13, 2011 |
| Last Updated: | September 14, 2011 |
| Health Authority: | Japan: Ministry of Education, Culture, Sports, Science and Technology |
Additional relevant MeSH terms:
|
Cell Transformation, Neoplastic Liver Neoplasms Neoplastic Processes Neoplasms Pathologic Processes |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on June 18, 2013