UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006690 |
|---|---|
| Receipt number | R000007907 |
| Scientific Title | Efficacy of NK1 receptor antagonist (aprepitant) in the cancer chemotherapies for hematologic malignancies. |
| Date of disclosure of the study information | 2011/11/09 |
| Last modified on | 2012/06/19 18:22:02 |
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Basic information
Public title
Efficacy of NK1 receptor antagonist (aprepitant) in the cancer chemotherapies for hematologic malignancies.
Acronym
Efficacy of aprepitant in the chemotherapies for hematologic malignancies.
Scientific Title
Efficacy of NK1 receptor antagonist (aprepitant) in the cancer chemotherapies for hematologic malignancies.
Scientific Title:Acronym
Efficacy of aprepitant in the chemotherapies for hematologic malignancies.
Region
| Japan |
Condition
Condition
hematologic malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of aprepitant on the cancer chemotherapies for hematologic malignancies in patients receiving aprepitant with patients receiving no aprepitant.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
conplete response (no vomiting, no salvage treatment) in day1 through 7.
Key secondary outcomes
complete response, frequency of nausea and vomiting, meal status, weight change
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
course 1 aprepitant (-)
course 2- aprepitant (+)
Interventions/Control_2
course 1 aprepitant (+)
course 2- aprepitant (+)
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
patients (>=20 years-old) with hematologic malignancies treated with cancer chemotherapies including moderately emetogenic agents or highly emetogenic agents
Key exclusion criteria
patients unable to answer the questions about efficacy of aprepitant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimiharu Uozumi |
Organization
Kagoshima University Hospital
Division name
Hematology and Immunology
Zip code
Address
Sakuragaoka 8-35-1, Kagoshima
TEL
099-275-5934
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiharu Uozumi |
Organization
Kagoshima University Hospital
Division name
Hematoilogy and Immunology
Zip code
Address
Sakuragaoka 8-35-1, Kagoshima
TEL
099-275-5934
Homepage URL
uosakana@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital, division of Hematology and Immunology
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
鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 08 | Day |
Last modified on
| 2012 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007907
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