UMIN ID: UMIN000002330
Registered date:12/08/2009
Japanease multi-center clinical trial to assess the inhibitory effects of branched chain amino acids on the recurrence after curative treatment of hepatocellular carcinoma
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Hepatocellular carcinoma |
| Date of first enrollment | 2009/08/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Diet therapy group Diet + BCAA therapy group |
Outcome(s)
| Primary Outcome | Time to recurrence of hepatocellular carcinoma |
|---|---|
| Secondary Outcome | Survival time, Change of hepatic reserve, Change of lipid metabolisum and glucose tolerance, Change of nutritional state, etc |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Impregnated patient 2.Complication of ascites, edema and hepatic coma 3.Intrahepatic cholangiocarcinoma and metastatic liver tumor 4.Patient who is difficult to keep a diet therapy going 5.Insulin-treated diabetic patient 6.HCV negative patient after interferon therapy 7.HBsAg positive patient, heavy user of alcohol (more than 60g/day/ ethanol) 8.Patient who is in treatment with antiviral drug (Interferon, Peg-interforon, Ribavirin, etc) 9.Patient who is complicated with renal dysfunction including dialysis. 10.Patient who is associated with heavy heart, lung and hematological disorder, or others. 11.Inegible patient at a physician's discretion |
Related Information
| Primary Sponsor | Ministry of Health, Labour and Welfare |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Research grant from tha Japanease Ministry of health, Labour and Walfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Uchimaru, Morioka, Iwate, 020-8505, Japan Japan |
| Telephone | |
| Affiliation | Iwate Medical University, School of Medicine Division of Gastroenterology and Hepatology,Department of Internal Medicine |
| scientific contact | |
| Name | Kazuyuki Suzuki |
| Address | Uchimaru, Morioka, Iwate, 020-8505, Japan Japan |
| Telephone | |
| Affiliation | Iwate Medical University, School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine |