UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006375 |
|---|---|
| Receipt number | R000007566 |
| Scientific Title | Study of antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with hematologic malignancy receiving highly emetogenic chemotherapy. |
| Date of disclosure of the study information | 2011/09/21 |
| Last modified on | 2011/09/20 14:43:46 |
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Basic information
Public title
Study of antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with hematologic malignancy receiving highly emetogenic chemotherapy.
Acronym
Study of antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with hematologic malignancy receiving highly emetogenic chemotherapy.
Scientific Title
Study of antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with hematologic malignancy receiving highly emetogenic chemotherapy.
Scientific Title:Acronym
Study of antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with hematologic malignancy receiving highly emetogenic chemotherapy.
Region
| Japan |
Condition
Condition
Hematologic malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of aprepitant combined with 5-HT3 receptor antagonist (aprepitant regimen) for chemotherapy-induced nausea and vomiting in patients with hematologic malignancy receiving highly emetogenic chemotherapy, and to compare the result of one year in the past retrospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Proportion of patients with no emesis
2) Proportion of patients with no nausea and no more than mild nausea
Key secondary outcomes
1) Proportion of patients with complete response (no emesis and no use of rescue medication)
2) Proportion of patients with complete protection (no emesis, no use of rescue medication, and no more than mild nausea)
3) Distribution of incidences of nausea and vomiting
4) Time to first emetic episode and time to first use of rescue medication
5) Food ingestion
6) Change in body weight
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dual therapy combined with aprepitant and 5HT3 receptor antagonist
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) Patients with hematologic malignancy receiving who first underwent highly emetogenic chemotherapy (the same patient receiving different regimen is allowed)
2) Written informed consent for participation in the study
Key exclusion criteria
1) Patient has a serious hepatic insufficiency or renal failure
2) Patient has nausea or vomiting within 24 hours prior to chemotherapy
3) Patient has been treated with antiemetic agents within 24 hours prior to chemotherapy
4) 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
5) Patient is pregnant or lactating woman, and woman who plans to become pregnant
6) Patient is currently treated with pimozide
7) Patient is judged inappropriate by the investigator as subject for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Okamura |
Organization
Kurume University Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kurume University Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
Homepage URL
Sponsor or person
Institute
Department of Hematology and Oncology, Kurume University Hospital
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
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 | 09 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
Management information
Registered date
| 2011 | Year | 09 | Month | 20 | Day |
Last modified on
| 2011 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007566
