UMIN-CTR Clinical Trial

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
Institute	University of Human Environments Graduate School of Nursing
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031006