Prevention of Breast Cancer-related Lymphedma With Tacrolimus
NCT ID: NCT04390685
Last Updated: 2021-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2020-02-26
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Tacrolimus ointment
Apply whole arm, in a thin layer, once daily for one year
Tacrolimus ointment
Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection
Control
No interventions assigned to this group
Interventions
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Tacrolimus ointment
Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection
Eligibility Criteria
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Inclusion Criteria
* Breast cancer with planned ALND
* postmenopausal or use of contraceptives
* good general health condition
* read and understand Danish
Exclusion Criteria
* bilateral breast cancer
* known allergy to tacrolimus or macrolides
* known lymphedema
* other malignant disease apart from keratinocyte cancer
* in medical treatment for diabetes mellitus
* known psychiatric condition which may influence participation
* known renal or hepatic function
18 Years
75 Years
FEMALE
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Mads Gustaf Jørgensen
Medical doctor, ph.d.-student.
Locations
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Sydvestjysk Sygehus
Esbjerg, , Denmark
Department of Plastic and Reconstructive Surgery
Odense, , Denmark
Sygehus Lillebælt Vejle
Vejle, , Denmark
Countries
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Other Identifiers
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2018-003416-50
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
S-20180134
Identifier Type: -
Identifier Source: org_study_id
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