UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018470 |
|---|---|
| Receipt number | R000021387 |
| Scientific Title | Nausea and vomiting Survey during mild emetic antineoplastic drug combination(doublet study) |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2018/06/14 16:42:36 |
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Basic information
Public title
Nausea and vomiting Survey during mild emetic antineoplastic drug combination(doublet study)
Acronym
Nausea and vomiting Survey during mild emetic antineoplastic drug combination(doublet study)
Scientific Title
Nausea and vomiting Survey during mild emetic antineoplastic drug combination(doublet study)
Scientific Title:Acronym
Nausea and vomiting Survey during mild emetic antineoplastic drug combination(doublet study)
Region
| Japan |
Condition
Condition
Malignant tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Breast surgery |
| Obstetrics and Gynecology | Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Survey its effectiveness in the case of expression situation and antiemetic therapy of acute and delayed gastrointestinal symptoms due to the combination therapy administered mild emetogenic antineoplastic agents (nausea and vomiting) has been implemented in daily practice to.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Complete Response
Key secondary outcomes
Complete Control,Total Control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The case of the first dose in the regimen of chemotherapy planned
2.Cases of combination chemotherapy of antineoplastic agents between mild emetic risk (antiemetics proper use guidelines in 2014 [Version 1.2]) is planned
Key exclusion criteria
1.Patients who experienced vomiting within chemotherapy before 24 hours
2.Day2 later also cases to use a mild emetic of anti-cancer drugs (except the oral anti-cancer agent)
3.Cases that enforce radiation therapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakata Yukio |
Organization
Hakodate Municipal hospital
Division name
Pharmaceutical department
Zip code
Address
1-10-1,Minatochiou,Hakodate,Hokkaido,Japan
TEL
0138-43-2000
y-sakata@hospital.hakodate.hokkaido.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakata Yukio |
Organization
Hakodate Municipal hospital
Division name
Pharmaceutical department
Zip code
Address
1-10-1,Minatochiou,Hakodate,Hokkaido,Japan
TEL
0138-43-2000
Homepage URL
y-sakata@hospital.hakodate.hokkaido.jp
Sponsor or person
Institute
Donan oncology supportive care study group(DOG)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
市立函館病院(北海道)
製鉄記念室蘭病院(北海道)
函館五稜郭病院（北海道）
函館中央病院（北海道）
日鋼記念病院（北海道）
苫小牧市立病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | 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
case-control study
Management information
Registered date
| 2015 | Year | 07 | Month | 29 | Day |
Last modified on
| 2018 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021387
