UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004624 |
|---|---|
| Receipt number | R000005516 |
| Scientific Title | Prospective study about the improvement of therapeutic invasiveness by oral intake of branched-chain amino acid (BCAA) supplement in hepatocellular carcinoma (HCC) patients after transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA) |
| Date of disclosure of the study information | 2010/11/29 |
| Last modified on | 2013/08/21 21:48:37 |
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Basic information
Public title
Prospective study about the improvement of therapeutic invasiveness by oral intake of branched-chain amino acid (BCAA) supplement in hepatocellular carcinoma (HCC) patients after transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA)
Acronym
Prospective study about the improvement of therapeutic invasiveness by oral intake of BCAA supplement in HCC patients after TACE and RFA
Scientific Title
Prospective study about the improvement of therapeutic invasiveness by oral intake of branched-chain amino acid (BCAA) supplement in hepatocellular carcinoma (HCC) patients after transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA)
Scientific Title:Acronym
Prospective study about the improvement of therapeutic invasiveness by oral intake of BCAA supplement in HCC patients after TACE and RFA
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether BCAA supplement could improve the therapeutic invasiveness such as the deterioration of liver metabolism and Child's score after TACE and RFA in HCC patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The improvement of the deterioration of liver metabolism (7 days after/ before TACE and RFA) and Child's score (3 months after/ before TACE and RFA) by oral intake of BCAA supplement.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Indirect calorimetry in pre-TACE and pre-RFA and 7 days after TACE and RFA on oral intake group of BCAA supplement
Interventions/Control_2
Indirect calorimetry in pre-TACE and pre-RFA and 7 days after TACE and RFA on non-oral intake group of BCAA supplement
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who were not adapted to the exclusion criteria were treated with segmental TACE and RFA.
Key exclusion criteria
Those who had refractory ascites, overt hepatic encephalopathy, uncontrolled esophageal varices, severe jaundice, Child's grade C and portal vein trunk thrombosis were excluded from the study. In addition, those who used intravenous albumin regularly were also excluded.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaya Saito |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5111
masaya@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Saito |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5111
Homepage URL
masaya@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kobe University Graduate 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
神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 26 | Day |
Last modified on
| 2013 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005516
