UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041695