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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031592
Receipt No. R000036063
Scientific Title Feasibility study of scalp cooling device for risk reduction of alopecia in patients with breast cancer
Date of disclosure of the study information 2018/03/06
Last modified on 2018/03/05

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Basic information
Public title Feasibility study of scalp cooling device for risk reduction of alopecia in patients with breast cancer
Acronym Feasibility study of scalp cooling device for risk reduction of alopecia in patients with breast cancer
Scientific Title Feasibility study of scalp cooling device for risk reduction of alopecia in patients with breast cancer
Scientific Title:Acronym Feasibility study of scalp cooling device for risk reduction of alopecia 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 To evaluate the efficacy and safety of scalp cooling device for risk reduction of alopecia in women with stageI/II/III breast cancer who needs adjuvant/neoadjuvant chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Proportion of patients with CTCAE grade0-1 alopecia after the completion of all cycles of chemotherapy
Key secondary outcomes Safety
Quality of life
Wig or cap use
Proportion of patients with grade0-1 alopecia after the completion of all cycles of chemotherapy distinguished by anthracycline(AC) and taxane

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
Device,equipment
Interventions/Control_1 Scalp cooling is performed from 30 min before start until 90 min (25 min for taxanes) after the end.
Pictures of scalp are taken at the time of each course start.
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 Diagnosed as primary breast cancer
Stage I to III
Patients scheduled to receive preoperative or postoperative adjuvant chemotherapy containing anthracycline and/or taxanes.
Key exclusion criteria Patients with blood malignancy (leukemia, non-Hodgikin lymphoma, other systemic lymphoma)
Patients with cold allergy
Any other reasons judged as inadequate to participate in this study by physicians.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Hirano
Organization Tokyo Women's Medical University
Division name Department of Breast Surgery, Medical Center East
Zip code
Address Nishi-oku 2-1-10, Arakawa-ku, Tokyo, Japan
TEL 03-3810-1111
Email hirano.akira@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira HIrano
Organization Tokyo Women's Medical University
Division name Department of Breast Surgery, Medical Center East
Zip code
Address Nishi-oku 2-1-10, Arakawa-ku, Tokyo, Japan
TEL 03-3810-1111
Homepage URL
Email hirano.akira@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Department of Breast Surgery, Medical Center East
Institute
Department

Funding Source
Organization Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Other
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 東京女子医科大学東医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 06 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
2018 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 06 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
2018 Year 03 Month 05 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036063

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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