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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035066
Receipt No. R000039974
Official scientific title of the study Effectiveness and safety of the hair loss restraint by scalp cooling enforcement addition in the breast cancer chemotherapy
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/29

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Basic information
Official scientific title of the study Effectiveness and safety of the hair loss restraint by scalp cooling enforcement addition in the breast cancer chemotherapy
Title of the study (Brief title) Effectiveness and safety of the hair loss restraint by scalp cooling enforcement addition in the breast cancer chemotherapy
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate effectiveness and safety of hair loss restraint by the scalp cooling enforcement addition for female breast cancer patients scheduled to receive chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary efficacy endpoints are successful hair preservation assessed using the CTCAE4.0scale at the end of 8 cycles of chemotherapy by a clinician unaware of treatment assignment, and device safety.
Key secondary outcomes

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Scalp cooling is performed, it starts 30 minutes before chemotherapy, and continues until 90 minutes after the end of chemotherapy.
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
75 years-old >=
Gender Female
Key inclusion criteria Patients stage1/2/3 breast cancer
Key exclusion criteria Patients who have malignant blood disease or scalp tumor or cold urticaria.
Target sample size 60

Research contact person
Name of lead principal investigator Tomoko Kurita
Organization Nippon Medical School Hospital
Division name Breast Surgical Oncorogy
Address 1-1-5, Sendagi,Bunkyo-ku,Tokyo
TEL 03-3822-2131
Email tomoko28@nms.ac.jp

Public contact
Name of contact person Rina Kanamaru
Organization Nippon Medical School Hospital
Division name Breast Surgical Oncorogy
Address 1-1-5, Sendagi,Bunkyo-ku,Tokyo
TEL 03-3822-2131
Homepage URL
Email rinakoizumi@nms.ac.jp

Sponsor
Institute Nippon Medical School Hospital
Breast Surgical Oncorogy
Institute
Department

Funding Source
Organization Nippon Medical School Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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 日本医科大学付属病院

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 03 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 29 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039974

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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