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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020800
Receipt No. R000024009
Scientific Title Low emetic chemotherapy induced nausea and vomiting: A prospective, multicenter, observational study
Date of disclosure of the study information 2016/01/29
Last modified on 2016/02/04

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Basic information
Public title Low emetic chemotherapy induced nausea and vomiting: A prospective, multicenter, observational study
Acronym Low emetic chemotherapy induced nausea and vomiting: A prospective, multicenter, observational study
Scientific Title Low emetic chemotherapy induced nausea and vomiting: A prospective, multicenter, observational study
Scientific Title:Acronym Low emetic chemotherapy induced nausea and vomiting: A prospective, multicenter, observational study
Region
Japan

Condition
Condition Malignant neoplasm
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to investigate the incidence of CINV and the risk factors predicting CINV in cancer patients in the first cycle of LEC.
Basic objectives2 Others
Basic objectives -Others The incidence of CINV and the risk factors predicting CINV in LEC
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of CINV and the risk factors predicting CINV in LEC
Key secondary outcomes 1.incidence of CINV (overall, acute phase and delayed phase)
2.pattern of nausea incidence and severity
3.decrease of food intake
4.rescue medication use

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.Male and female patients (aged over 20 years) who were low emetic chemotherapy naive and scheduled to receive at least one cycles of chemotherapy
2.Patients can note in the patient diaries
3.Patients gave written informed consent
Key exclusion criteria 1.Patients experienced CINV within 24 hours before chemotherapy
2.Patients judged unqualified for any reasons by the principal investigator or investigators at study sites
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinobu Hayashi
Organization National Kyushu Medical Center
Division name Department of pharmacy
Zip code
Address 1-8-1 Jigyohama, Chuo-ku, Fukuoka, JAPAN
TEL 092-852-0700
Email nenten-ph@umin.org

Public contact
Name of contact person
1st name
Middle name
Last name Toshinobu Hayashi
Organization National Kyushu Medical Center
Division name Department of pharmacy
Zip code
Address 1-8-1 Jigyohama, Chuo-ku, Fukuoka, JAPAN
TEL 092-852-0700
Homepage URL
Email nenten-ph@umin.org

Sponsor
Institute Commitee of academic, society of pharmacist in national hospital organization kyushu
Institute
Department

Funding Source
Organization POLICY-BASED MEDICAL SERVICE FOUNDATION
Organization
Division
Category of Funding Organization Non profit foundation
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 九州がんセンター(福岡県)
九州医療センター(福岡県)
熊本医療センター(熊本県)
長崎医療センター(長崎県)
別府医療センター(大分県)
鹿児島医療センター(鹿児島県)
小倉医療センター(福岡県)
佐賀病院(佐賀県)
都城病院(宮崎県)
熊本再春荘病院(熊本県)
嬉野医療センター(佐賀県)
福岡病院(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2013 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design:
Cohort study

This prospective observational study was conducted from August 2013 to July 2014.

Patients:
Male and female patients (aged over 20 years) who were chemotherapy naive and scheduled to receive at least one cycles of single-day LEC were eligible for inclusion in the study.

Key inclusion criteria:
1.Male and female patients (aged over 20 years) who were low emetic chemotherapy naive and scheduled to receive at least one cycles of chemotherapy
2.Patients can note in the patient diaries
3.Patients gave written informed consent

Exclusion criteria:
1.Patients experienced CINV within 24 hours before chemotherapy
2.Patients judged unqualified for any reasons by the principal investigator or investigators at study sites

Procedures:
Patients completed the daily diary beginning before chemotherapy (on day 1) and for a total of five calendar days.
Patients recorded the time and date of emetic episodes, the severity of nausea and food intake (0-100 VAS), and use of rescue
medication (type and dosage).

Management information
Registered date
2016 Year 01 Month 29 Day
Last modified on
2016 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024009

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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