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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036906
Receipt No. 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 2019/05/09

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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
Email 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
Email ishiba0313@gmail.com

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department

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
Email 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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 31 Day
Last modified on
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041695

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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