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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031534
Receipt No. R000036004
Scientific Title Study of effectiveness and safety on the hair loss restraint by scalp cooling with scalp cooling device in the breast cancer chemotherapy
Date of disclosure of the study information 2018/03/01
Last modified on 2018/12/28

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Basic information
Public title Study of effectiveness and safety on the hair loss restraint by scalp cooling with scalp cooling device in the breast cancer chemotherapy
Acronym Hair loss restraint by scalp cooling enforcement
(Scalp cooling study)
Scientific Title Study of effectiveness and safety on the hair loss restraint by scalp cooling with scalp cooling device in the breast cancer chemotherapy
Scientific Title:Acronym Hair loss restraint by scalp cooling enforcement
(Scalp cooling study)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate effectiveness and safety of hair loss restraint by the scalp cooling enforcement addition for female breast cancer patients scheduled to receive chemotherapy causing high hair loss.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Rate of grade 0 or 1 of hair loss, according to CTCAE ver4.0 classification
Key secondary outcomes Rate of hair loss restraint in each evaluation timing
Hair loss accompanying symptom
Hair loss period
Safety
Adverse events

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 This study uses scalp cooling device (Paxman cooler, U.K.) for about 180 minutes during receiving chemotherapy.(30 minutes before and 90 minutes after chemotherapy)

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 1)Histologically confirmed primary breast cancer
2)Stage I, II or III
3)Female aged 20 to 75 years old.
4)The case for that is planned anthracycline, taxane-based chemotherapy and in that hair loss is expected.
5)No history of the chemotherapy for the malignant tumor
6)Signed informed consent of the patient for registration.
Key exclusion criteria 1)Chilly allergy
2)Cold agglutinin disease
3)Any scalp skin tumor
4)History of radiation for head
5)Temporomandibular disorder or disease to a chin
6)Any other cases who are regarded as inadequate for study enrollment by the attending doctors
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eriko Tokunaga
Organization National Hospital Organization Kyushu Cancer Center
Division name Breast Oncology
Zip code
Address 3-1-1 Notame Minami-ku Fukuoka-shi,Fukuoka
TEL 092-541-3231
Email tokunaga.eriko.pw@mail.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Okamoto
Organization National Hospital Organization Kyushu Cancer Center
Division name Breast Oncology
Zip code
Address 3-1-1 Notame Minami-ku Fukuoka-shi,Fukuoka
TEL 092-541-3231
Homepage URL
Email okamoto.masahiro.zu@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Kyushu Cancer Center
Institute
Department

Funding Source
Organization National Hospital Organization Kyushu Cancer Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 独立行政法人国立病院機構 九州がんセンター(福岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
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 01 Day
Last modified on
2018 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036004

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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