UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035066 |
|---|---|
| Receipt number | R000039974 |
| Scientific Title | 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 | 2022/12/02 09:17:10 |
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Basic information
Public title
Effectiveness and safety of the hair loss restraint by scalp cooling enforcement addition in the breast cancer chemotherapy
Acronym
Effectiveness and safety of the hair loss restraint by scalp cooling enforcement addition in the breast cancer chemotherapy
Scientific Title
Effectiveness and safety of the hair loss restraint by scalp cooling enforcement addition in the breast cancer chemotherapy
Scientific Title:Acronym
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
| 1st name | Tomoko |
| Middle name | |
| Last name | Kurita |
Organization
Nippon Medical School Hospital
Division name
Breast Surgical Oncorogy
Zip code
113-8602
Address
1-1-5, Sendagi,Bunkyo-ku,Tokyo
TEL
03-3822-2131
tomoko28@nms.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kurita |
Organization
Nippon Medical School Hospital
Division name
Breast Surgical Oncorogy
Zip code
113-8602
Address
1-1-5, Sendagi,Bunkyo-ku,Tokyo
TEL
03-3822-2131
Homepage URL
tomoko28@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Breast Surgical Oncorogy
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Institutional Review Board of Nippon Medical School Foundation
Address
1-1-5, Sendagi,Bunkyo-ku,Tokyo
Tel
03-5802-8202
officetokutei@nms.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
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 |
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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 25 | 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
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 29 | Day |
Last modified on
| 2022 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039974
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
