UMIN-CTR Clinical Trial

Basic information
Public title	A prospective surveillance for chemotherapy-induced nausea and vomiting
Acronym	A prospective surveillance for chemotherapy-induced nausea and vomiting
Scientific Title	A prospective surveillance for chemotherapy-induced nausea and vomiting
Scientific Title:Acronym	A prospective surveillance for chemotherapy-induced nausea and vomiting
Region	Japan

Condition
Condition	malignant tumor
Classification by specialty	Medicine in general Gastroenterology Pneumology Hematology and clinical oncology Gastrointestinal surgery Obsterics and gynecology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the contents of the antiemetic therapy, incidence of nausea/vomiting, and patient demographic and characteristics associated with highly and moderately emetogenic chemotherapy.
Basic objectives2	Others
Basic objectives -Others	To construct the evidence towards the establishment of a suitable antiemetic therapy according to each patient.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Complete Response (no emesis and no rescue therapy) in overall phase (1 to 7 days)
Key secondary outcomes	1) Complete Response in acute (day 1) and delayed (2 to 7 days) phase 2) Control rate of nausea/vomiting 3) dietary intake 4) Incidence of constipation 5) Degree of satisfaction to treatment of nausea and vomiting

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patient is scheduled to receive his/her first course of highly or moderately emetogenic chemotherapy 2) Patient is planning the chemotherapy of at least two or more courses 3) Patient is able to complete study diary
Key exclusion criteria	1) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting 2) Patient is judged that it is unsuitable as a study patient by investigator (e.g. patient cannot complete study diary)
Target sample size	900

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroaki Matsuo
Organization	Hiroshima University Hospital
Division name	Department of Pharmaceutical Services
Zip code
Address	Kasumi 1-2-3 Minami-ku, Hiroshima
TEL	082-257-5555
Email	hmatsuo@hiroshima-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Satoru Izumitani
Organization	Hiroshima University Hospital
Division name	Department of Pharmaceutical Services
Zip code
Address	Kasumi 1-2-3 Minami-ku, Hiroshima
TEL	082-257-5575
Homepage URL
Email	izumit@hiroshima-u.ac.jp

Sponsor
Institute	Department of Pharmaceutical Services, Hiroshima University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 03 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	2011 Year 07 Month 20 Day
Date of IRB	2011 Year 08 Month 31 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2013 Year 08 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information	1) Clarify the contents of the antiemetic therapy, incidence of nausea/vomiting, and patient demographic and characteristics associated with highly and moderately emetogenic chemotherapy. 2) Pharmacist recognizes the problem associated with results of surveillance. 2) Construct the evidence towards the establishment of a suitable antiemetic therapy according to each patient.

Management information
Registered date	2011 Year 10 Month 03 Day
Last modified on	2019 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007662