UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Nutritional support in cirrhotic patients with hepatocellular carcinoma
Title of the study (Brief title)	Nutritional support in cirrhotic patients with hepatocellular carcinoma(NSTHCC)
Region	Japan

Condition
Condition	Liver cirrhosis with hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We investigated the efficacy of branched-chain amino acid (BCAA)-enriched nutrient combined with an alpha-glucosidase inhibitor in cirrhotic patients with hepatocellular carcinoma by prospective randomized trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in insulin resistance
Key secondary outcomes	1) Evaluation for nutritional status 2) Incidence of complicating disease 3) Prognosis

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Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	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 group; 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) and protein (13.5 g) from the aforementioned calculated nutritional intake.
Interventions/Control_2	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. [II group]:Aminoleban EN + Voglibose group;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).
Interventions/Control_3	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. [III group]:Meal group (control group)
Interventions/Control_4	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 of ideal body weight per day. [I group]:Aminoleban EN group; Administration of Aminoleban EN was same as above.
Interventions/Control_5	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 of ideal body weight per day. [II group]:Meal group (control group)
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	125

Research contact person
Name of lead principal investigator	Takahiro Yamasaki
Organization	Yamaguchi University School of Medicine
Division name	The first department of internal medicine
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Email

Public contact
Name of contact person
Organization	Yamaguchi University School of Medici
Division name	The first department of internal medicine
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Homepage URL
Email

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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	山口大学医学部附属病院（山口県）

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 07 Month 14 Day
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 09 Month 04 Day
Last modified on	2016 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000004993