UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031534
Receipt number 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 2023/03/14 10:03:43

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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
Influence of the hair loss after the chemotherapy


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 confirme 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

120


Research contact person

Name of lead principal investigator

1st name Eriko
Middle name
Last name Tokunaga

Organization

National Hospital Organization Kyushu Cancer Center

Division name

Breast Oncology

Zip code

811-1395

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 Chinami
Middle name
Last name Koga

Organization

National Hospital Organization Kyushu Cancer Center

Division name

Breast Oncology

Zip code

811-1395

Address

3-1-1 Notame Minami-ku Fukuoka-shi,Fukuoka

TEL

092-541-3231

Homepage URL


Email

koga.chinami.qb@mail.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Kyushu Cancer Center

Institute

Department

Personal name



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

National Hospital Organization Kyushu Cancer Center

Address

3-1-1 Notame Minami-ku Fukuoka-shi,Fukuoka

Tel

092-541-3231

Email

601-rinri@mail.hosp.go.jp


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

No longer recruiting

Date of protocol fixation

2018 Year 02 Month 06 Day

Date of IRB

2018 Year 02 Month 06 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2025 Year 04 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

2018 Year 03 Month 01 Day

Last modified on

2023 Year 03 Month 14 Day



Link to view the page

Value
https://center6.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