UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006456 |
|---|---|
| Receipt number | R000007662 |
| Scientific Title | A prospective surveillance for chemotherapy-induced nausea and vomiting |
| Date of disclosure of the study information | 2011/10/03 |
| Last modified on | 2019/04/09 12:50:04 |
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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 | Obstetrics 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
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
hmatsuo@hiroshima-u.ac.jp
Public contact
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
izumit@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Pharmaceutical Services, Hiroshima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007662
