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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027043
Receipt No. 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 2018/07/24

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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
Middle name
Last name Yoshie Hara
Organization University of Human Environments Graduate School of Nursing
Division name Doctor of Nursing Programs
Zip code
Address 3-220, Ebata-cho, Obu-city, Aichi, 474-0035, Japan
TEL 0562-43-0701
Email dn15008@uhe.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshie Hara
Organization University of Human Environments Graduate School of Nursing
Division name Doctor of Nursing Programs
Zip code
Address 3-220, Ebata-cho, Obu-city, Aichi, 474-0035, 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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2017 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
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
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.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


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