Phase III trial of the usefulness of new antidepilation conpound, DHL-HisZnNa, against the antineoplastic drug - induced depilation in breast cancer patients
Phase 3
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000014840
- Lead Sponsor
- Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
Not provided
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.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A depilatory grade (rate of Grade2 of CTCAEv4.0 )
- Secondary Outcome Measures
Name Time Method Depilation periods (periods of Grade2 in CTCAEv4.0) Periods which patients needed Wig Accessory-symptoms with Depilation (itchiness and pain) Adverse event