UMIN-CTR Clinical Trial

Basic information
Public title	Reserch of nail care during cancer chemotherapy
Acronym	Reserch of nail care during cancer chemotherapy
Scientific Title	Reserch of nail care during cancer chemotherapy
Scientific Title:Acronym	Reserch of nail care during cancer chemotherapy
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore the effects of gel-nails and nail polish on finger nails on the quality of life (QOL) of breast cancer patients during chemotherapy.
Basic objectives2	Others
Basic objectives -Others	Efficacy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FACT-B,FACT-Tax(before gel-nails and nail polish,3 times in chemtherapy,3 weeks after chemotherapy)
Key secondary outcomes	degrees of nail toxicity

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	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	apply gel nails on finger nails every 3 weeks(four times) during adjuvant paclitaxel, then 3 week after the last dose of paclitaxel.
Interventions/Control_2	apply nail polish on finger nails every 3 weeks(four times) during adjuvant paclitaxel, then 3 week after the last dose of paclitaxel
Interventions/Control_3	None
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	Female
Key inclusion criteria	20 years old or older Clinically diagnosed breast cancer Expected adjuvant paclitaxel after complete from of Anthracycline base adjuvant chemotherapy
Key exclusion criteria	unable to obtain to informed consent The physicians in charge judge it difficult for their patients to participate in the program. History of allergy by gel nail or nail polish. Severe nail disorder.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Misato Middle name Last name Osaka
Organization	St. Luke's International Hospital
Division name	oncology center
Zip code	104-8560
Address	9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan
TEL	03-3541-5151
Email	miohat@luke.ac.jp

Public contact
Name of contact person	1st name Misato Middle name Last name Osaka
Organization	St. Luke's International Hospital
Division name	oncology center
Zip code	104-8560
Address	9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan
TEL	03-3541-5151
Homepage URL
Email	miohat@luke.ac.jp

Sponsor
Institute	St. Luke's International Hospital
Institute
Department

Funding Source
Organization	THE COSMETOLOGY RESEARCH FOUNDATION
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St. Luke's International University, Clinical Trial Office
Address	Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan
Tel	03-3541-5151
Email	kenkyukikaku@luke.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	2019 Year 10 Month 25 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	Preinitiation
Date of protocol fixation	2019 Year 10 Month 29 Day
Date of IRB
Anticipated trial start date	2019 Year 10 Month 29 Day
Last follow-up date	2020 Year 12 Month 10 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 10 Month 24 Day
Last modified on	2019 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043723