The investigation for the improvement of nutrition using a branched-chain amino acid (BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with hepatocellular carcinoma

The investigation for the improvement of nutrition using a branched-chain amino acid (BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with hepatocellular carcinoma - The investigation for the improvement of nutrition using a branched-chain amino acid (BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with hepatocellular carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001255

Enrollment

Registered

2008-07-22

Start date

2008-07-01

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

Liver cirrhosis associated with hepatocellular carcinoma

Interventions

Diet group: Diet therapy alone (30-35kcal/kg/day) during treatments and follow up periods Aminoreban EN group: Oral supplementation with two pack of Aminoreban EN (one pack during a day, ie at sometim

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hepatocellular carcinoma recieving hepatic arterial infusion chemotherapy 2. Virgin case of hepatic arterial infusion chemotherapy 3. Not relate to pervious treatment for hepatocellular carcinoma 4. Need to administration of hepatic arterial infusion chemotherapy 5. WBC>=3,000/mm3 6. Plt>=50,000/ul 7. Age is more 20 years old and less or equal 80 years old, male and female 8. Need to wash out period for one week, for patients who peviously administerd Aminoreban EN or another BCAA-enriched nutrient

Exclusion criteria

Exclusion criteria: 1. Extrahepatic metastasis 2. History of anaphylactic reaction for amino acid nutrient 3. Severe renal dysfunction 4. Congenital amino-acid metabolism abnormality 5. Milk allergy

Design outcomes

Primary

Measure	Time frame
occurence of the following events: ascites, peripheral edema, bleeding of gastrointerstinal tract, hepatic encephalopathy, others	—

Secondary

Measure	Time frame
SF-36 nutrition status using an indirect calorimeter(RQ) reserved liver function(Alb) BTR Change of blood cell count(WBC, RBC, lymphocyte, Plt)	—

Countries

Japan

Contacts

Public ContactTakahiro Yamasaki

Yamaguchi Univercity Graduate School of Medicine Department of Gastroenterology and Hepatology

0836-22-2239

Outcome results

None listed

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