UMIN-CTR Clinical Trial

Basic information
Public title	Japan PHarmacological Audit study of Safety and Efficacy in Real world (Phase-R) Nausea and Vomiting Study
Acronym	Phase-R Nausea and Vomiting Study
Scientific Title	Japan PHarmacological Audit study of Safety and Efficacy in Real world (Phase-R) Nausea and Vomiting Study
Scientific Title:Acronym	Phase-R Nausea and Vomiting Study
Region	Japan

Condition
Condition	malignancy
Classification by specialty	Medicine in general Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of olanzapine for nausea and vomiting in patients with cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	average nausea NRS on day 2
Key secondary outcomes	adverse events symptom relief scale

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inpatients with cancer being cared for by hospital palliative care teams aged 18 years or older who receive olanzapine treatment for nausea and vomiting
Key exclusion criteria	none
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Isseki Maeda
Organization	Osaka University Hospital
Division name	Oncology Center
Zip code
Address	2-15 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-5111
Email	maeda@pm.med.osaka-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Keisuke Ariyoshi
Organization	The University of Tokyo, The Institute of Medical Science
Division name	Department of Palliative Medicine
Zip code
Address	4-6-1 Shiroganedai, Minato-ku, Tokyo, Japan
TEL	03-3443-8111
Homepage URL	http://www.jortc.jp/
Email	k-ariyoshi@umin.ac.jp

Sponsor
Institute	The University of Tokyo, The Institute of Medical Science
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	独立行政法人　国立がん研究センター東病院（千葉県） 小牧市民病院（岐阜県） 神戸大学大学院（兵庫県） 大阪大学医学部附属病院（大阪府） 聖隷浜松病院（静岡県） 東京大学医学部附属病院（東京都） 東京大学医科学研究所附属病院（東京都） 九州がんセンター（福岡県） 国立病院機構　近畿中央胸部疾患センター（大阪府） 独立行政法人　国立がん研究センター中央病院（東京都） 筑波大学附属病院（茨城県） 帝京大学附属病院（東京都） 名古屋市立大学病院（愛知県） 聖路加国際病院（東京都） 横浜労災病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 12 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	Completed
Date of protocol fixation	2014 Year 01 Month 09 Day
Date of IRB	2014 Year 05 Month 14 Day
Anticipated trial start date	2016 Year 01 Month 12 Day
Last follow-up date	2016 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	study design: cohort study patient recruitment: eligible patients who are cared for by a participating hospital palliative care team from January, 2016 measurements: average nausea NRS, number of vomiting episode, symptom relief scale, primary disease, previous treatments, concomitant treatments

Management information
Registered date	2016 Year 01 Month 08 Day
Last modified on	2019 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023589