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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000014840 |
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Date of registration:
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15/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase III trial of the usefulness of new antidepilation conpound, DHL-HisZnNa, against the antineoplastic drug - induced depilation in breast cancer patients
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Scientific title:
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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 |
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Date of first enrolment:
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2014/08/04 |
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Target sample size:
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100 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017164 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase III
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Countries of recruitment
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Japan
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Contacts
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Name:
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Shinji Ohno |
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Address:
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Fukuoka 811-1395, Japan
Japan |
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Telephone:
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092-541-3231 |
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Email:
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sohno@nk-cc.go.jp |
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Affiliation:
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National Hospital Organization Kyushu Cancer Center Clinical reserch institute |
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Name:
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Masafumi Inomata |
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Address:
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1-1 Idaigaoka, Yufu, Oita 879-5593, Japan
Japan |
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Telephone:
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097-586-5843 |
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Email:
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inomata@oita-u.ac.jp |
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Affiliation:
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Oita University Faculty of Medicine Department of Gastroenterological and Pediatric Surgery |
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Key inclusion & exclusion criteria
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Inclusion 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.)
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Female
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Health Condition(s) or Problem(s) studied
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breast cancer
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Intervention(s)
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therapy group
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Primary Outcome(s)
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A depilatory grade (rate of Grade2 of CTCAEv4.0 )
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Secondary Outcome(s)
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Depilation periods (periods of Grade2 in CTCAEv4.0) Periods which patients needed Wig Accessory-symptoms with Depilation (itchiness and pain) Adverse event
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Source(s) of Monetary Support
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Aderans Company Limited
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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