UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005712 |
|---|---|
| Receipt number | R000006747 |
| Scientific Title | Prevention of the chemotherapy-induced oral mucositis by the rebamipide in breast cancer patients (Phase II) |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2019/03/22 16:12:23 |
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Basic information
Public title
Prevention of the chemotherapy-induced oral mucositis by the rebamipide in breast cancer patients
(Phase II)
Acronym
Prevention of the chemotherapy-induced oral mucositis by the rebamipide in breast cancer patients
-Cinderella Study BC2011-
Scientific Title
Prevention of the chemotherapy-induced oral mucositis by the rebamipide in breast cancer patients
(Phase II)
Scientific Title:Acronym
Prevention of the chemotherapy-induced oral mucositis by the rebamipide in breast cancer patients
-Cinderella Study BC2011-
Region
| Japan |
Condition
Condition
Oral mucositis
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify a preventive effect of rebamipide on chemotherapy-induced oral mucositis in breast cancer patients under the standard oral care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence rate of oral mucositis with grade >=1
Key secondary outcomes
1)Incidence rate of oral mucositis with grade >=2
2)Incidence rate of oral mucositis with grade >=3
3)Maximum grade of oral mucositis during chemotherapy cycle1-3
4)Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Oral care (3 cycles: 63 days)
Rebamipide (3 cycles: 63 days)
Interventions/Control_2
Oral care (3 cycles: 63 days)
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)Patients diagnosed histopatholoogically as invasive breast cancer by needle biopsy
2)Patients who will be administrated with FEC100 or TC chemotherapy with cycles >= 3
3)Not permitted the prior treatments such as chemotherapy, molecular targeted therapy, radiotherapy, and immunotherapy, excluding preoperative hormonal therapy
4)Patient who is normal in status of oral mucosa (grade 0)
5)Patient who doesn't have dental caries that needs treatment to exclude influence on oral mucositis
6)Patient who doesn't have incompatible artificial tooth
7) Patient who is not taking medicines* from which influence on oral mucositis is reported within two weeks at the time of registration
*:Rebamipide, Allopurinol, Camostat Mesilate, Polaprezinc, Pilocarpine Hydrochloride, Cevimeline Hydrochloride Hydrate, NSAID, Irsogladine Maleate, Teprenone, Lafutidine
However, use with a temporary a dose of NSAID is enabled
8)Performance status of 0 or 1
9)Aged 20 to 70 years old, women
10)Patient with whom inspection value meets the following requirements at the time of registration
i.WBC >= 4000/mm3 or ANC >= 2000/mm3
ii. Hb >= 9.0 g/dL
iii. Platelet >= 100,000/mm3
iv. AST/ALT <= 2.5 x ULN
v. T-Bil/D-Bil <= ULN
vi. Cr <= 1.5 x ULN
11)LVEF more than 55%
12)Normal or without clinical problem in the electrocardiogram
13)Without interstitial pneumonia or pulmonary fibrosis
14)Patients with written informed consent
Key exclusion criteria
1)Patient with impossible oral ingestion of medicine
2)Patients with allergy history for rebamipide
3)Patient with breast cancer relapse or metastasis
4)Women during pregnancy, and women who has likelihood of pregnancy or the intention or breast-feeding
5)Patient who judged that doctor is improper excluding the above-mentioned
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norikazu Masuda |
Organization
National Hospital Organization
Osaka National Hospital
Division name
Surgery, breast oncology
Zip code
Address
2-1-14,Houenzaka,Chuou-ku,Osaka
TEL
06-6946-3555
nmasuda@alpha.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norikazu Masuda |
Organization
National Hospital Organization
Division name
Surgery
Zip code
Address
2-1-14,Houenzaka,Chuou-ku,Osaka
TEL
06-6946-3555
Homepage URL
nmasuda@alpha.ocn.ne.jp
Sponsor or person
Institute
Cinderella Study Group
Institute
Department
Personal name
Funding Source
Organization
NPO
Sakai Clinical Research Support Center
Organization
Division
Category of Funding Organization
Non profit foundation
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
独立行政法人国立病院機構 大阪医療センター（大阪府）
独立行政法人国立病院機構 九州がんセンター（福岡県）
独立行政法人国立病院機構 四国がんセンター（愛媛県）
市立堺病院（大阪府）
岩手医科大学（岩手県）
独立行政法人国立病院機構 北海道がんセンター（北海道）
新潟県立がんセンター新潟病院（新潟県）
労働者健康福祉機構 大阪労災病院（大阪府）
八尾市立病院（大阪府）
広島市立広島市民病院（広島県）
広島大学病院（広島県）
うえお乳腺外科（大分県）
博愛会相良病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 01 | 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
| 2013 | Year | 06 | 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 | 06 | Month | 03 | 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=R000006747
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