UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031592 |
|---|---|
| Receipt number | 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 | 2020/03/06 14:06:31 |
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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 | Akira |
| Middle name | |
| Last name | Hirano |
Organization
Tokyo Women's Medical University
Division name
Department of Breast Surgery, Medical Center East
Zip code
116-8567
Address
Nishi-oku 2-1-10, Arakawa-ku, Tokyo, Japan
TEL
03-3810-1111
hirano.akira@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | HIrano |
Organization
Tokyo Women's Medical University
Division name
Department of Breast Surgery, Medical Center East
Zip code
116-8567
Address
Nishi-oku 2-1-10, Arakawa-ku, Tokyo, Japan
TEL
03-3810-1111
Homepage URL
hirano.akira@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Department of Breast Surgery, Medical Center East
Institute
Department
Personal name
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
MHLW Certified Clinical Research Review Board, Tohoku University
Address
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel
022-718-0461
office@nrs.hosp.tohoku.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
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 07 | 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 | 03 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036063
