UMIN-CTR Clinical Trial

Public title

Phase III trial of the usefulness of new antidepilation conpound, DHL-HisZnNa, against the antineoplastic drug - induced depilation in breast cancer patients

Acronym

Phase III trial of the usefulness of new antidepilation conpound, DHL-HisZnNa, against the antineoplastic drug - induced depilation in breast cancer patients

Scientific Title

Phase III trial of the usefulness of new antidepilation conpound, DHL-HisZnNa, against the antineoplastic drug - induced depilation in breast cancer patients

Scientific Title:Acronym

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

breast cancer

Classification by specialty

Hematology and clinical oncology	Breast surgery	Dermatology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Shinji Ohno

Organization

National Hospital Organization Kyushu Cancer Center

Division name

Clinical reserch institute

Zip code

Address

Fukuoka 811-1395, Japan

TEL

092-541-3231

Email

sohno@nk-cc.go.jp

Name of contact person

1st name
Middle name
Last name	Masafumi Inomata

Organization

Oita University Faculty of Medicine

Division name

Department of Gastroenterological and Pediatric Surgery

Zip code

Address

1-1 Idaigaoka, Yufu, Oita 879-5593, Japan

TEL

097-586-5843

Homepage URL

Email

inomata@oita-u.ac.jp

Institute

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

Institute

Department

Personal name

Organization

Aderans Company Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

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）

Date of disclosure of the study information

2014

Year

08

Month

15

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

2014

Year

08

Month

01

Day

Date of IRB

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

Other related information

Registered date

2014

Year

08

Month

12

Day

Last modified on

2019

Year

02

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017164