UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The surveillance study of nausea and vomiting associated with transcatheter arterial chemoembolization for hepatocellular carcinoma
Title of the study (Brief title)	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	Takayuki Yakushijin
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3621
Email	yakushijin@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	Takayuki Yakushijin
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3621
Homepage URL
Email	yakushijin@gh.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006850