UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038946 |
|---|---|
| Receipt number | R000044402 |
| Scientific Title | Efficacy and safety of hair loss suppression by additional scalp cooling during breast cancer chemotherapy |
| Date of disclosure of the study information | 2019/12/23 |
| Last modified on | 2022/07/11 19:53:07 |
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Basic information
Public title
Efficacy and safety of hair loss suppression by additional
scalp cooling during breast cancer chemotherapy
Acronym
scalp cooling
Scientific Title
Efficacy and safety of hair loss suppression by additional
scalp cooling during breast cancer chemotherapy
Scientific Title:Acronym
scalp cooling
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For patients with a confirmed diagnosis of breast cancer who have undergone pre- and post-operative chemotherapy for stage I / II / III initial breast cancer, epilation by scalp cooling for epilation with frequent side effects Investigate whether there is an inhibitory effect and consider safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of hair loss at the end of chemotherapy and during chemotherapy (CTCAE ver.4.0)
Hair loss of eyebrows and eyelashes
Whether wearing a hat or wig
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
[Device used] PAXMAN scalp cooling device (Century Medical Co., Ltd.)
[Cooling time] About 3 and a half hours
[Intervention period] Anthracycline 4 courses and taxane 4 courses are being administered, assuming intervention for patients with primary breast cancer.
[Administration drug] Both anthracycline (FEC, AC, EC) and taxane (DTX, PTX) are administered. Weight loss can be up to 25%. Anti-HER2 drugs may be included.
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Patients histologically diagnosed with breast cancer
2) Women who are over 20 years old and under 60 years old
3) Patients who are scheduled to undergo chemotherapy and hair loss is predicted
4) Patients who have given their consent in writing
5) Patients who are scheduled to have 8 or more courses of chemotherapy including anthracycline and taxane anticancer drugs before or after surgery (weight loss is up to 25%)
Key exclusion criteria
1) Patients with malignant blood disease
2) Patients with cold allergies
3) Patients with cold agglutinin disease
4) Patients with a tumor on the scalp
5) Patients receiving high-dose anticancer drugs as pretreatment for stem cell transplantation
6) Patients undergoing head radiation therapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nana |
| Middle name | |
| Last name | Komatsu |
Organization
Showa University
Division name
Breast center
Zip code
1428555
Address
1-5-8 Hatanodai Shinagawa Tokyo
TEL
0337848000
nanakomatsu.0503@gmail.com
Public contact
Name of contact person
| 1st name | Nana |
| Middle name | |
| Last name | Komatsu |
Organization
Showa University
Division name
Breast center
Zip code
1428555
Address
1-5-8 Hatanodai Shinagawa Tokyo
TEL
0337848000
Homepage URL
nana.k@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Century Medical
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
1-5-8 Hatanodai Shinagawa Tokyo
Tel
0337848000
nanakomatsu.0503@gmail.com
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
| 2019 | Year | 12 | Month | 23 | 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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 20 | Day |
Last modified on
| 2022 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044402
