UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038379
Receipt number R000043723
Scientific Title Reserch of nail care during cancer chemotherapy
Date of disclosure of the study information 2019/10/25
Last modified on 2019/11/08 13:55:52

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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 or person

Institute

St. Luke's International Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043723


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name