UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study on the efficacy and the safety of scalp cooling system to prevent hair loss in breat cancer patients receiving chemotherapy
Title of the study (Brief title)	The study on the efficacy and the safety of scalp cooling system to prevent hair loss in breat cancer patients receiving chemotherapy
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the completion rate of adjuvant chemotherapy, the efficacy of hair loss prevention, the safety and the degrees of comfort of scalp cooling system in breast cancer patients scheduled to receive postoperative adjuvant chemotherapy (AC or TC).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the proportion of patients which were able to complete 4 cycles of postoperative adjuvant AC or TC therapy in patients who used the scalp-cooling system
Key secondary outcomes	the degrees of comfort, satisfaction, the efficacy of hair loss prevention, the rates of adverse events, and the rates of metastases in patients who used the scalp-cooling system

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	Maneuver
Interventions/Control_1	This study uses scalp-cooling equipment (Paxman cooler, U.K.) for about 180 minutes in the middle of receiving postoperative chemotherapy either AC(60/600 mg/m2) or TC(75/600 mg/m2).
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	80 years-old >
Gender	Female
Key inclusion criteria	1)primary breast cancer 2)Stage I or II 3)Patient underwent radical operation. 4)Patient scheduled to receive 4 cycles of postoperative adjuvant chemotherapy using either AC or TC. 5)Ages 20 years or more, less than 80 years. 6)ECOG performance status of 0,1 or 2. 7)Female 8)Required baseline laboratory parameters are as follows: Neutrophil count 1,500/mm3 or more Plt 100,00/mm3 or more AST and ALT less than 60 IU/L T-Bil less than 1.5mg/dL Cre less than 1.5mg/dL 9)Signed informed consent of the patient for registration.
Key exclusion criteria	1)Any skin diseases 2)alopecia 3)history of radiation for head 4)allergy for doxorubicin, docetaxel, or cyclophosphamide 5)allergy for silicone 6)Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 7)history of ischemic heart disease (angina pectoris or myocardial infarction) or cardiomyopathy 8)clinically significant infectious disease 9)history of interstitial pneumonia or pulmonary fibrosis 10)uncontrolled diabetes mellitus or under insulin treatment 11)the other malignant cancers 12)mental disease, or difficult-to-treat psychiatric patient 13)Raynaud's disease 14)Cold agglutinin disease 15)Cryoglobulinemia 16)Any other cases who are regarded as inadequate for study enrollment by the attending doctors
Target sample size	40

Research contact person
Name of lead principal investigator	Takayuki Kinoshita
Organization	National Cancer Center Hospital
Division name	Department of Breast Surgery
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Email	takinosh@ncc.go.jp

Public contact
Name of contact person	Sho Shiino
Organization	National Cancer Center Hospital
Division name	Department of Breast Surgery
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Homepage URL
Email	sshiino@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)

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	2017 Year 11 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 30 Day
Anticipated trial start date	2011 Year 07 Month 04 Day
Last follow-up date	2018 Year 07 Month 03 Day
Date of closure to data entry	2018 Year 07 Month 03 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Sponser initiated clinical trial

Management information
Registered date	2017 Year 11 Month 15 Day
Last modified on	2018 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030845