UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007135 |
|---|---|
| Receipt number | R000007957 |
| Scientific Title | Study on effective prevention of chemotherapy-induced nausea and vomiting based on genetic polymorphism |
| Date of disclosure of the study information | 2012/01/25 |
| Last modified on | 2021/06/08 15:27:01 |
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Basic information
Public title
Study on effective prevention of chemotherapy-induced nausea and vomiting based on genetic polymorphism
Acronym
Clinical pharmacogenetics study for antiemetic therapy
Scientific Title
Study on effective prevention of chemotherapy-induced nausea and vomiting based on genetic polymorphism
Scientific Title:Acronym
Clinical pharmacogenetics study for antiemetic therapy
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the association between the effectiveness of standard prophylactic antiemetic therapy and genetic polymorphism in prevention of chemotherapy-induced emesis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Proportion of complete response (defined as no emesis and no rescue treatment). [Time Frame: overall; 0-120hr(during and post chemotherapy), acute phase;0-24hr, delayed phase 24-120hr]
Key secondary outcomes
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) Breast cancer patients
2) Patients who receive the standard dose of AC combination
3) 20 years-old over at the time of giving informed consent
4) ECOG PS 0-2
5) Adequate organ function obtained within 2 weeks prior to registration. Laboratory values must be as follows;
WBC >= 3000/mm3
PLT >= 100000/mm3
AST <= 100 IU/L
ALT <= 100 IU/L
T-Bill <= 2.0 mg/dL
S-Cr <= 1.5 mg/dL
6)Informed consent by the document
Key exclusion criteria
1) Known prior severe hypersensitivity to anthracyclines, cyclophosphamide, 5HT3 receptor antagonist, corticosteroids and NK-1 receptor antagonists
2) Patients who do not have enough whole body state to the antineoplastic agents treatment
3) Pregnant, breastfeeding or expecting woman
4) Patient with severe uncontrollable diabetes mellitus
5) Known symptomatic brain metastasis
6) Other clinical difficulties in this study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yong-Il KIM |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Medical Oncology
Zip code
Address
2-12-12, Sumiyoshi, Naka-ku, Hamamatsu, 430-8558, Japan
TEL
053-474-2222
ykim@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daiki TSUJI |
Organization
Univercity of Shizuoka
Division name
School of Pharmaceutical Science
Zip code
Address
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL
054-264-5674
Homepage URL
d-tsuji@u-shiuzoka-ken.ac.jp
Sponsor or person
Institute
Univercity of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Univercity of Shizuoka
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 25 | 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
Main results already published
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood samples are collected from breat cancer patients who received AC combination regimen. Relationship between genitic polymorphisms and antiemetic effect are assessed
Management information
Registered date
| 2012 | Year | 01 | Month | 25 | Day |
Last modified on
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007957
