UMIN-CTR Clinical Trial

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
Last 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
Email	nmasuda@alpha.ocn.ne.jp

Public contact
1st 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
Email	nmasuda@alpha.ocn.ne.jp

Sponsor
Institute	Cinderella Study Group
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006747