UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009702 |
|---|---|
| Receipt number | R000011373 |
| Scientific Title | Efficacy of Aprepitant for Hematology and Oncology. |
| Date of disclosure of the study information | 2013/01/20 |
| Last modified on | 2022/07/23 13:57:22 |
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Basic information
Public title
Efficacy of Aprepitant for Hematology and Oncology.
Acronym
Efficacy of Aprepitant for Hematology and Oncology.
Scientific Title
Efficacy of Aprepitant for Hematology and Oncology.
Scientific Title:Acronym
Efficacy of Aprepitant for Hematology and Oncology.
Region
| Japan |
Condition
Condition
Hematological malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In the first step , we investigate a situation of nausea and vomiting and anorexia in patients receiving chemotherapy for hematological tumors. Next step, we evaluate the efficacy of aprepitant in patients who induced nausea and vomiting and anorexia in the first step. In addition, we assess the influence of aprepitant on antitumor effect in patients administerd steroids as cancer chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The difference of the incidence of nausea and vomiting
Key secondary outcomes
The proportion of patients with Complete Response (no emesis and no rescue therapy) in the overall phase (0-120 hour after administration of antitumor agent).
The proportion of patients with Complete Response ( no emesis and no rescue therapy ) in Day 1 or Day 2 - Day 5.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
aprepitant(d1-3)
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. Received the chemotherapy for blood tumor
2. able to record the onset of vomiting and nausea in a symptom diary
3. patients who induced nausea and vomiting and anorexia and rescue therapy in the first chemotherapy.
4. Performance Status(PS) of 0-2
5. estimated life expectancy of at least 3 months
6. aspartate aminotransferase (AST) (glutamic oxaloacetic transaminase (GOT)) and alanine aminotransferase(ALT) (glutamic pyruvic transaminase (GPT))<2.5 x upper limit of the normal range at the facility
7. total bilirubin <1.5 x upper limit of the normal range at the facility
8. creatinine <1.5 x upper limit of the normal range at the facility
Key exclusion criteria
1. chemotherapy within 6 days before study day 1 or between days 1 to 6.
2. Antiemetic therapy prior to 48 hr of chemotherapy.
3. Corticosteroids therapy within 72 hr before study day 1 or duration of study
4. Radiation therapy to the abdomen or pelvis within 6 days before study day 1 or duration of study
5. known central nervous system malignancy
6. following drug therapy within 6 days before study day 1
- clarithromycin, ketoconazole,
itraconazole -
7. following drug therapy within 4 weeks before study day 1
- barbiturate, rifampicin, phenytoin, carbamazepine -
8. pregnant, nursing or possibly pregnant
women
9. Patients judged inappropriate for this study by physicians
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Akifumi |
| Middle name | |
| Last name | Takaori |
Organization
Kyoto University Hospital
Division name
Department of Hematology and Oncology
Zip code
606-8507
Address
54 Shogoin Kawaharacho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-751-3150
atakaori@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadakazu |
| Middle name | |
| Last name | Kondo |
Organization
Kyoto University Hospital
Division name
Department of Hematology and Oncology
Zip code
606-8507
Address
54 Kawaramachi, Seigoin, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-366-7550
Homepage URL
tadakazu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital,Department of Hematology and Oncology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University, Graduate School and Faculty of Medicine, Ethic Committee
Address
54 Kawaramachi, Seigoin, Sakyo-ku, Kyoto-shi, Kyoto
Tel
075-753-4642
ethcom@kuhp.kyoto-u.ac.jp
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
https://hematol.kuhp.kyoto-u.ac.jp
Publication of results
Unpublished
Result
URL related to results and publications
https://hematol.kuhp.kyoto-u.ac.jp
Number of participants that the trial has enrolled
30
Results
Frequency of nausea and vomitting decreased with the addition of aprepitant.
Results date posted
| 2022 | Year | 07 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with hematologic malignancies receiving chemotherapy
Participant flow
After obtaining explanatory consent, registration is made.
Adverse events
None
Outcome measures
Frequency of nausea and vomitting
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 06 | Day |
Last modified on
| 2022 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011373
