UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase III trial of the usefulness of new antidepilation conpound, DHL-HisZnNa, against the antineoplastic drug - induced depilation in breast cancer patients
Title of the study (Brief title)	Phase III trial of the usefulness of new antidepilation conpound, DHL-HisZnNa, against the antineoplastic drug - induced depilation in breast cancer patients
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the clinical utility of DHL-HisZnNa against the adjuvant chemotherapy - induced depilation in breast cancer patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	A depilatory grade (rate of Grade2 of CTCAEv4.0 )
Key secondary outcomes	Depilation periods (periods of Grade2 in CTCAEv4.0) Periods which patients needed Wig Accessory-symptoms with Depilation (itchiness and pain) Adverse event

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	Other
Interventions/Control_1	therapy group
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	80 years-old >=
Gender	Female
Key inclusion criteria	1) Pathological breast cancer patients 2) Primary breast cancer having the following chemotherapies plans a) The regimen containing anthracycline (AC, EC, and FEC 21-day x4 course) and the regimen containing taxane (PTX, and DTX, 21-day x4 course) b) The regimen containing anthracycline (AC, EC, and FEC 21-day x4 course) or the regimen containing taxane (TC, PTX, and DTX, 21-day x4 course) 3) Female 20 and over and aged 80 and below in age at the time of the registration 4) Performance status (ECOG) is 0 or 1. 5) The function of main internal organs (the marrow, the heart, the lung, the liver, a kidney, etc.) is held. a) White blood cell count: 3,000/mm3 >= WBC <= 12,000/mm3 b) The number of neutrophils: 1,500/mm3 >= c) The number of platelets: 100,000/mm3 >= d) Hemoglobin: 9.0 g/dL >= e) Total bilirubin: <= 2.0 mg/dL f) AST, ALT: <= normal value x2 in each institution g) Serum creatinine: <= normal value in each institution h) Creatinine clearance : 50 >= (based on the formula* of Cockcroft-Gault) mL/min * [Formula of Cockcroft-Gault] Female Ccr = weight (kg) x (140- age)/(72 x serum creatinine level) x 0.85 6) Written informed consent
Key exclusion criteria	1)The anamnesis of critical drug hypersensitivity 2)Antineoplastic drug medication is contraindications; The anamnesis of the critical hypersensitivity to the ingredient of anthracycline or the paclitaxel. a)The case which has an anamnesis of hypersensitivity to ingredients, of cosmetics and/or hair restorers b) Cardiac dysfunction or its anamnesis c) Critical myelosuppression d) Critical renal damage e) Critical liver damage f) Infectious disease suspected g) Chicken poxthe case h) Pregnancy or pregnancy is possible. 4) Critical complications (diabetes with poor control, hypertension with poor control, heart failure, renal failure, hepatic failure, etc.)
Target sample size	100

Research contact person
Name of lead principal investigator	Shinji Ohno
Organization	National Hospital Organization Kyushu Cancer Center
Division name	Clinical reserch institute
Address	Fukuoka 811-1395, Japan
TEL	092-541-3231
Email	sohno@nk-cc.go.jp

Public contact
Name of contact person	Masafumi Inomata
Organization	Oita University Faculty of Medicine
Division name	Department of Gastroenterological and Pediatric Surgery
Address	1-1 Idaigaoka, Yufu, Oita 879-5593, Japan
TEL	097-586-5843
Homepage URL
Email	inomata@oita-u.ac.jp

Sponsor
Institute	Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization	Aderans Company Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立病院機構九州がんセンター（福岡県） 愛知県がんセンター中央病院（愛知県） 筑波大学（茨城県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 12 Day
Last modified on	2019 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017164