UMIN-CTR Clinical Trial

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

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Cancer Center Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

None

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

11

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Sponser initiated clinical trial

Registered date

2017

Year

11

Month

15

Day

Last modified on

2018

Year

11

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030845