UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005839 |
|---|---|
| Receipt number | R000006850 |
| Scientific Title | The surveillance study of nausea and vomiting associated with transcatheter arterial chemoembolization for hepatocellular carcinoma |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2017/08/28 10:19:15 |
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Basic information
Public title
The surveillance study of nausea and vomiting associated with transcatheter arterial chemoembolization for hepatocellular carcinoma
Acronym
The surveillance study of nausea and vomiting associated with transcatheter arterial chemoembolization for hepatocellular carcinoma
Scientific Title
The surveillance study of nausea and vomiting associated with transcatheter arterial chemoembolization for hepatocellular carcinoma
Scientific Title:Acronym
The surveillance study of nausea and vomiting associated with transcatheter arterial chemoembolization for hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate symptom including nausea and vomiting induced by transacatheter arterial chemoembolization for hepatocellular carcinoma, change of the level of emetic factor including substance P and serotonin, and antiemetic effects of antagonists for NK1 receptor and 5-HT3 receptor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes of this study is the incidence of nausea and vomiting without antiemetic drugs and the rate of symptom amelioration by antiemetic drugs after transcatheter arterial chemoembolization for hepatocellular carcinoma.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
control
Interventions/Control_2
NK1 receptor antagonist
Interventions/Control_3
5-HT3 receptor antagonist
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients who are diagnosed as hepatocellular carcinoma and candidates for transcatheter arterial chemoembolization
Key exclusion criteria
(1)Child Pugh score C
(2)hepatic encephalopathy II or more
(3)total bilirubin 3.0mg/dL or more
(4)the patients who are treated for neuropsychiatric disorder
(5)the patients who takes anti-anxiety agent
(6)the patients who takes Pimozide
(7)the patients who are judged to be ineligible for entry of this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Yakushijin |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3621
yakushijin@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Yakushijin |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3621
Homepage URL
yakushijin@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 01 | 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
| 2011 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 23 | Day |
Last modified on
| 2017 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006850
