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Nutritional support in cirrhotic patients with hepatocellular carcinoma

Nutritional support in cirrhotic patients with hepatocellular carcinoma - Nutritional support in cirrhotic patients with hepatocellular carcinoma(NSTHCC)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004158
Enrollment
125
Registered
2010-09-06
Start date
2010-09-01
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 with hepatocellular carcinoma

Interventions

Patients with glucose intolerance Daily nutritional intake for each group was calculated as 25-30 kcal with 1.2-1.3 g of protein per kilogram of ideal body weight per day. [I group]:Aminoleban EN gr
One pack of the BCAA-enriched mixture (Aminoleban EN
Otsuka, Tokyo, Japan) used as late evening snack (LES) food (at 22:00) contains 210 kcal. Actual daily nutritional intake from meals was determined by subtracting the calorie content of LES (210 kcal)
Administration of Aminoleban EN was same as above. One 0.2mg tablet of alfa-glucosidase inhibitor voglibose(Takeda, Osaka, Japan) was orally administered before every meal(0.6mg/day). Patients with
Administration of Aminoleban EN was same as above. Patients without glucose intolerance Daily nutritional intake for each group was calculated as 25-30 kcal with 1.2-1.3 g of protein per kilogram o

Sponsors

The first department of internal medicine,Yamaguchi University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients who can take sufficient diet. 2)Patients who are diadosed as HCC based on the imaging findings and require HCC treatment. 3)Either initial treatment or recurrent treatment is no object. 4)age, over 20 years and regardless of gender 5)Either outpatient or inpatient is no object. Ptients need to be admitted to hospital during HCC treatment. 6)Patients who can take a wash out period for one week, when either Aminoleban EN or another BCAA-enriched mixture previously was administered.

Exclusion criteria

Exclusion criteria: 1)Patients with sensitivities for BCAA-enriched mixture. 2)Patients with sensitivities for alfa-glucosidase inhibitor. 3)Diabetic patients who are used oral antidiabetic agent or insulin. 4)Diabetic patients who had severe diadetic ketosis, diadetic coma, or precoma stage. 5)Decompensated liver cirrhostic patients who were difficult to treat(for example, total bilirubin, over 3.0mg/dl; hepatic coma, coma grade over grade II; treatment-resistant ascites). 6)Patients who had serum albumin, <2.5g/dl 7)Patients who had severe renal failure(i.e. serum creatinine, over 2mg/dl) 8)Patients who had severe hernia, stenosis of colon or inflammation of colon. 9)Patients who were difficult to take sufficient diet(i.e.protein control). 10)Patients who had congenital amino-acid metabolism abnormality. 11)Patients who had milk allergy. 12)Patients who were disqualified by doctor in attendance.

Design outcomes

Primary

MeasureTime frame
Changes in insulin resistance

Secondary

MeasureTime frame
1) Evaluation for nutritional status 2) Incidence of complicating disease 3) Prognosis

Countries

Japan

Outcome results

None listed

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