UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004158
Receipt No. R000004993
Scientific Title Nutritional support in cirrhotic patients with hepatocellular carcinoma
Date of disclosure of the study information 2010/09/06
Last modified on 2016/04/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Nutritional support in cirrhotic patients with hepatocellular carcinoma
Acronym Nutritional support in cirrhotic patients with hepatocellular carcinoma(NSTHCC)
Scientific Title Nutritional support in cirrhotic patients with hepatocellular carcinoma
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Takahiro Yamasaki
Organization Yamaguchi University School of Medicine
Division name The first department of internal medicine
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yamaguchi University School of Medici
Division name The first department of internal medicine
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2010 Year 07 Month 14 Day
Date of IRB
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

Other
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-open-bin/ctr_e/ctr_view.cgi?recptno=R000004993

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.