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
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
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
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
