UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009507 |
|---|---|
| Receipt number | R000011171 |
| Scientific Title | The effect of rebamipide for the protection of the oral mucositis in the breast cancer patients |
| Date of disclosure of the study information | 2012/12/09 |
| Last modified on | 2019/03/22 16:21:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of rebamipide for the protection of the oral mucositis in the breast cancer patients
Acronym
Cinderella-01
Scientific Title
The effect of rebamipide for the protection of the oral mucositis in the breast cancer patients
Scientific Title:Acronym
Cinderella-01
Region
| Japan |
Condition
Condition
bresat cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
examination of the effect of rebamipide for the protection of the oral mucositis during the chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of the oral mucositis over grade 1
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rebamipide
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1. early breast cancer
2. planned FEC or TC chemotherapy on the neo or post-operation adjuvant chemotherapy
3. no treatment for BC
4. normal organ function
5. writtten IC
Key exclusion criteria
1. difficult in the oral administration
2. metastatic of reccurent Brast cancer
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | norikazu masuda |
Organization
Cinderella study group
Division name
NHO Osaka national Hsp
Zip code
Address
2-1-14,houenzaka, Chuou-ku, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Cinderella study group
Division name
NHO Osaka national Hsp
Zip code
Address
TEL
Homepage URL
nmasuda@alpha.ocn.ne.jp
Sponsor or person
Institute
Cinderella study group
Institute
Department
Personal name
Funding Source
Organization
Sakai Clinical support center
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 12 | 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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011171
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
