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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014840

Enrollment

100

Registered

2014-08-15

Start date

2014-08-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

therapy group

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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.)

Design outcomes

Primary

Measure	Time frame
A depilatory grade (rate of Grade2 of CTCAEv4.0 )	—

Secondary

Measure	Time frame
Depilation periods (periods of Grade2 in CTCAEv4.0) Periods which patients needed Wig Accessory-symptoms with Depilation (itchiness and pain) Adverse event	—

Countries

Japan

Contacts

Public ContactMasafumi Inomata

Oita University Faculty of Medicine Department of Gastroenterological and Pediatric Surgery

inomata@oita-u.ac.jp097-586-5843

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026