UMIN-CTR Clinical Trial

Basic information
Public title	Effect of a scalp cooling device in the prevention of chemotherapy-induced alopecia in breast cancer patients
Acronym	Effect of a scalp cooling device in the prevention of chemotherapy-induced alopecia in breast cancer patients
Scientific Title	Effect of a scalp cooling device in the prevention of chemotherapy-induced alopecia in breast cancer patients
Scientific Title:Acronym	Effect of a scalp cooling device in the prevention of chemotherapy-induced alopecia in breast cancer patients
Region	Japan

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

Objectives
Narrative objectives1	To prevent chemotherapy-induced alopecia, use of a scalp cooling device is one of the most effective methods. All previous studies that used the Paxman Scalp Cooling System were carried out in Europe and United States where the patient's head shapes are quite different from those of Asians. In this study, we assess the effectiveness of a scalp cooling device in Japanese breast cancer patients who undergo adjuvant chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade0 [no hair loss] or grade 1 [<50% hair loss not requiring a wig]were considered to have hair preservation) at the end of 4 cycles of chemotherapy(TC or weekly PTX) by the physician in charge.
Key secondary outcomes	1.Wig or head cap use 2.Differences in success rates according to chemotherapy regimen 3.Safety assessment: Adverse events related to device use 4.Safety assessment: Head skin metastasis at 5 years later

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	1.Scalp cooling using the Paxman Scalp Cooling Device was done 30 minutes prior to, during and 90 minutes after each chemo therapy infusion. 2.Patients are instructed to perform gentler hair care than usual as much as possible at home.
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	Not applicable
Gender	Female
Key inclusion criteria	1.ECOG performance status 0 or 1 2.Adequate bone marrow,heart,liver and renal function 3.Informed consent is obtainable from the subject herself in documented form using the Consent Form
Key exclusion criteria	1.Previous chemotherapy treatment 2.Already have alopecia >grade 1 by CTCAE v4.0 3.History of migraine headaches, hypothyroidism, uncontrolled diabetes, and anorexia. 4.Any condition for contraindication of chemotherapy 5.Multiple active cancers (homochromous multiple cancers, or heterochromous multiple cancers with a cancer-free period of less than 5 years prior to randomization) Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer 6.Difficulty to participate in this study due to mental illness or psychiatric symptoms 7.Any other reasons recognized as inadequate to participate in this study by doctors
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Haruru Middle name Last name Kotani
Organization	Aichi Cancer Center
Division name	Department of Breast Oncology
Zip code	464-8681
Address	1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL	052-762-6111
Email	k.haruru@aichi-cc.jp

Public contact
Name of contact person	1st name Haruru Middle name Last name Kotani
Organization	Aichi Cancer Center
Division name	Department of Breast Oncology
Zip code	464-8681
Address	1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL	052-762-6111
Homepage URL
Email	k.haruru@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center
Institute
Department

Funding Source
Organization	self funding
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	Aichi Cancer Center
Address	1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
Tel	052-762-6111
Email	k.haruru@aichi-cc.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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 26 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	2017 Year 05 Month 22 Day
Date of IRB	2017 Year 06 Month 29 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2019 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date	2017 Year 06 Month 23 Day
Last modified on	2020 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031959