UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030489 |
|---|---|
| Receipt number | R000034602 |
| Scientific Title | Prevention of chemotherapy-induced stomatitis in women with breast cancer using dexamethasone mouthwash : Multicenter randomized, phase 2 trial. |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2022/02/03 16:38:51 |
* 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
Prevention of chemotherapy-induced stomatitis in women with breast cancer using dexamethasone mouthwash : Multicenter randomized, phase 2 trial.
Acronym
Prevention of chemotherapy-induced stomatitis in women with breast cancer using dexamethasone mouthwash : Multicenter randomized, phase 2 trial.
Scientific Title
Prevention of chemotherapy-induced stomatitis in women with breast cancer using dexamethasone mouthwash : Multicenter randomized, phase 2 trial.
Scientific Title:Acronym
Prevention of chemotherapy-induced stomatitis in women with breast cancer using dexamethasone mouthwash : Multicenter randomized, phase 2 trial.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
prevention of chemotherapy-induced stomatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of stomatitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
dexamethasone mouthwash
Interventions/Control_2
control
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients with invasive breast cancer
2. Planned regimen is EC or TC
3. No previous chemotherapy
4. Patients without stomatitis at recruit
5. Without of inadequate dentures
6. Patients that PS is 0-1
Key exclusion criteria
1. Advanced breast cancer patients
2. Patients with pregnant
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Eguchi |
Organization
Nagasaki University Graduate School of Biomedical Science
Division name
Surgery
Zip code
852-8501
Address
1-17-1, Sakamoto-machi
TEL
095-849-7316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Kuba |
Organization
Nagasaki University Graduate School of Biomedical Science
Division name
Surgery
Zip code
852-8501
Address
1-7-1, Sakamoto-machi, Nagasaki city
TEL
095-849-7316
Homepage URL
skuba@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Cancer Society
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
Nagasaki University Hospital Clinical Research Ethical Committee
Address
1-7-1, Sakamoto-machi, Nagasaki city
Tel
0958197726
rinshou7726@umin.ac.jp
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
| 2017 | Year | 12 | Month | 20 | 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
121
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
| 2017 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2022 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034602
