UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036906 |
|---|---|
| Receipt number | R000041695 |
| Scientific Title | the efficiency and safety of the new deodorant pad for breast cancer with skin ulcerations or diffusion |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2019/12/26 16:39:46 |
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Basic information
Public title
the efficiency and safety of the
deodorAnt Pad against Odor and uLceration for LOcal advanced breast cancer
Acronym
APOLLO trial
Scientific Title
the efficiency and safety of the new deodorant pad for breast cancer with skin ulcerations or diffusion
Scientific Title:Acronym
breast cancer deodorant pad test
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the efficacy and safety against of the new deodorant pad in the breast cancer patients with ulcerations or effusion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
A trial: the comparison of the
deodorant effect between the new deodorant pad and the traditional pad for three days
B trial: the safety of the continuous use of the deodorant pad for one month
Key secondary outcomes
deodorant effect
the frequency to change the pad
the work sheet result
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
deodorant pad for breast cancer
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
breast cancer patients with ulcerations or effusion
Key exclusion criteria
Patients in bad condition
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Ishiba |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Breast Surgery
Zip code
1138677
Address
18-22, 3 chome, Honkomagome, Bunkyo-ku, Tokyo, JAPAN
TEL
03-3823-2101
ishiba0313@gmail.com
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Ishiba |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Breast Surgery
Zip code
1138677
Address
18-22, 3 chome, Honkomagome, Bunkyo-ku, Tokyo, JAPAN
TEL
03-3823-2101
Homepage URL
ishiba0313@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Juntendo University Nerima Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address
18-22, 3 chome, Honkomagome, Bunkyo-ku, Tokyo, JAPAN
Tel
03-3823-2101
ishiba0313@gmail.com
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
| 2019 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 31 | Day |
Last modified on
| 2019 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041695
