UMIN-CTR Clinical Trial

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
Email	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
Email	nana.k@med.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044402