UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027043
Receipt number R000031006
Scientific Title A quasi-experimental study on effects of the hot compress to prevent occurrence of induration caused by fulvestrant in patients with breast cancer
Date of disclosure of the study information 2017/05/01
Last modified on 2019/11/20 15:44:02

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Basic information

Public title

A quasi-experimental study on effects of the hot compress to prevent occurrence of induration caused by fulvestrant in patients with breast cancer

Acronym

A quasi-experimental study on effects of the hot compress to prevent occurrence of induration caused by fulvestrant in patients with breast cancer

Scientific Title

A quasi-experimental study on effects of the hot compress to prevent occurrence of induration caused by fulvestrant in patients with breast cancer

Scientific Title:Acronym

A quasi-experimental study on effects of the hot compress to prevent occurrence of induration caused by fulvestrant in patients with breast cancer

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine effects of the hot compress before intramuscular injection to prevent occurrence of induration caused by fulvestrant.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

muscle hardness

Key secondary outcomes

skin reaction in the site of the hot compress, degree of comfort and unpleasantness by the hot compress, time of injecting the medication, difficulty of depressing the syringe plunger in injecting


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

We use the hot pack on the one side of the buttock for 15 minutes.

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

Female

Key inclusion criteria

postmenopausal woman with breast cancer,
patient who has administered intramuscularly fulvestrant treatment more than three months, person who agrees to participate this study

Key exclusion criteria

person who complicated metastasis to bone and lung, person with skin diseases and the induration of the injection site in the buttocks

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Yoshie
Middle name
Last name Hara

Organization

University of Human Environments Graduate School of Nursing

Division name

Doctor of Nursing Programs

Zip code

474-0035

Address

3-220, Ebata-cho, Obu-city, Aichi, Japan

TEL

0562-43-0701

Email

dn15008@uhe.ac.jp


Public contact

Name of contact person

1st name Yoshie
Middle name
Last name Hara

Organization

University of Human Environments Graduate School of Nursing

Division name

Doctor of Nursing Programs

Zip code

474-0035

Address

3-220, Ebata-cho, Obu-city, Aichi, Japan

TEL

0562-43-0701

Homepage URL


Email

dn15008@uhe.ac.jp


Sponsor or person

Institute

University of Human Environments Graduate School of Nursing

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the Institutional Review Board at the University of Human Environments

Address

3-220, Ebata-cho, Obu-city, Aichi, Japan

Tel

0562-43-0701

Email

m-oda@uhe.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

2017 Year 05 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

Completed

Date of protocol fixation

2017 Year 04 Month 22 Day

Date of IRB

2017 Year 05 Month 19 Day

Anticipated trial start date

2017 Year 05 Month 19 Day

Last follow-up date

2020 Year 03 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

2017 Year 04 Month 18 Day

Last modified on

2019 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031006


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name