UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004158
Receipt number 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 16:38:46

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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