UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031592
Receipt number R000036063
Scientific Title Feasibility study of scalp cooling device for risk reduction of alopecia in patients with breast cancer
Date of disclosure of the study information 2018/03/06
Last modified on 2020/03/06 14:06:31

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Basic information

Public title

Feasibility study of scalp cooling device for risk reduction of alopecia in patients with breast cancer

Acronym

Feasibility study of scalp cooling device for risk reduction of alopecia in patients with breast cancer

Scientific Title

Feasibility study of scalp cooling device for risk reduction of alopecia in patients with breast cancer

Scientific Title:Acronym

Feasibility study of scalp cooling device for risk reduction of alopecia in patients with breast cancer

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of scalp cooling device for risk reduction of alopecia in women with stageI/II/III breast cancer who needs adjuvant/neoadjuvant chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Proportion of patients with CTCAE grade0-1 alopecia after the completion of all cycles of chemotherapy

Key secondary outcomes

Safety
Quality of life
Wig or cap use
Proportion of patients with grade0-1 alopecia after the completion of all cycles of chemotherapy distinguished by anthracycline(AC) and taxane


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

Scalp cooling is performed from 30 min before start until 90 min (25 min for taxanes) after the end.
Pictures of scalp are taken at the time of each course start.

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

Diagnosed as primary breast cancer
Stage I to III
Patients scheduled to receive preoperative or postoperative adjuvant chemotherapy containing anthracycline and/or taxanes.

Key exclusion criteria

Patients with blood malignancy (leukemia, non-Hodgikin lymphoma, other systemic lymphoma)
Patients with cold allergy
Any other reasons judged as inadequate to participate in this study by physicians.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Hirano

Organization

Tokyo Women's Medical University

Division name

Department of Breast Surgery, Medical Center East

Zip code

116-8567

Address

Nishi-oku 2-1-10, Arakawa-ku, Tokyo, Japan

TEL

03-3810-1111

Email

hirano.akira@twmu.ac.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name HIrano

Organization

Tokyo Women's Medical University

Division name

Department of Breast Surgery, Medical Center East

Zip code

116-8567

Address

Nishi-oku 2-1-10, Arakawa-ku, Tokyo, Japan

TEL

03-3810-1111

Homepage URL


Email

hirano.akira@twmu.ac.jp


Sponsor or person

Institute

Tokyo Women's Medical University
Department of Breast Surgery, Medical Center East

Institute

Department

Personal name



Funding Source

Organization

Tokyo Women's Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

MHLW Certified Clinical Research Review Board, Tohoku University

Address

2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan

Tel

022-718-0461

Email

office@nrs.hosp.tohoku.ac.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

東京女子医科大学東医療センター(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 06 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 01 Month 25 Day

Date of IRB

2018 Year 03 Month 02 Day

Anticipated trial start date

2018 Year 03 Month 06 Day

Last follow-up date

2020 Year 07 Month 31 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 05 Day

Last modified on

2020 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036063


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name