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Japanease multi-center clinical trial to assess the inhibitory effects of branched chain amino acids on the recurrence after curative treatment of hepatocellular carcinoma

Japanease multi-center clinical trial to assess the inhibitory effects of branched chain amino acids on the recurrence after curative treatment of hepatocellular carcinoma - HCC prevention study by BCAA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002330
Enrollment
200
Registered
2009-08-12
Start date
2009-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

Diet therapy group Diet + BCAA therapy group

Sponsors

Ministry of Health, Labour and Welfare
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The following HCC patients who are curatively treated with resection or RFA. 1.20 years of age and older. 2.HCV RNA positive liver cirrhosis and 2.8-4.0 g/dl in serum albumin level. 3.New-onset HCC (no extrahepatic lesion, no more than 3lesions and the largest measuring 3cm and below). 4.Clinical diagnosis with imaging tests and tumor markers, add to pathological findings in impossible cases. 5.Comfirmation of no recurrence with CE-CT or CE-US, MRI at a month after treatment.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Time to recurrence of hepatocellular carcinoma

Secondary

MeasureTime frame
Survival time, Change of hepatic reserve, Change of lipid metabolisum and glucose tolerance, Change of nutritional state, etc

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026