UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022582 |
|---|---|
| Receipt number | R000025854 |
| Scientific Title | Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2019/05/30 13:37:08 |
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Basic information
Public title
Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients
Acronym
Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients
Scientific Title
Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients
Scientific Title:Acronym
Examination of efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore efficacy and safety of oral cryotherapy to prevent oral mucositis due to chemotherapy in breast cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of all grade oral mucositis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
oral cryotherapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The patients who had a diagnosis of invasive breast cancer by needle biopsy or tissue biopsy
2. FEC(EC)100/TC therapy enforcement planned patients
3. The patients who do not receive previous treatment for breast cancer
4. The patients who do not have oral mucositis before treatment
5. The patients without inadequate dentures
6. The patients that PS is 0-1
7. Age is women 80 years or younger 20 years old or older at the time of the agreement acquisition
8. The patients having more than 55% of left ventricular ejection fractions (LVEF) in an echocardiography
9. The patients without the abnormality clinical in an electrocardiogram
10. The patients that an agreement was obtained in a document
Key exclusion criteria
1. Advanced or metastatic breast cancer
2. A pregnant woman and the patients who may be pregnant or the patients whom we are nursing
3. The patients whom a study person in charge judged to be inadequate as study patients
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Eguchi |
| Middle name | |
| Last name | Susumu |
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 | Kuba |
| Middle name | |
| Last name | Sayaka |
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
Nagasaki University Graduate School of Biomedical Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
Sakamoto-machi
Tel
095-819-7726
no
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
| 2016 | Year | 06 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | 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
| 2016 | Year | 06 | Month | 02 | Day |
Last modified on
| 2019 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025854
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
