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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029984
Receipt No. R000030845
Scientific Title The study on the efficacy and the safety of scalp cooling system to prevent hair loss in breat cancer patients receiving chemotherapy
Date of disclosure of the study information 2017/11/20
Last modified on 2018/11/13

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Basic information
Public title The study on the efficacy and the safety of scalp cooling system to prevent hair loss in breat cancer patients receiving chemotherapy
Acronym The study on the efficacy and the safety of scalp cooling system to prevent hair loss in breat cancer patients receiving chemotherapy
Scientific Title The study on the efficacy and the safety of scalp cooling system to prevent hair loss in breat cancer patients receiving chemotherapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Takayuki Kinoshita
Organization National Cancer Center Hospital
Division name Department of Breast Surgery
Zip code
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
1st name
Middle name
Last name Sho Shiino
Organization National Cancer Center Hospital
Division name Department of Breast Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2011 Year 06 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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