Status:
UNKNOWN
Prevention of Breast Cancer-related Lymphedma With Tacrolimus
Lead Sponsor:
Odense University Hospital
Conditions:
Lymphedema
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Tacrolimus ointment may prevent lymphedema by inhibition of CD4+T cells.
Eligibility Criteria
Inclusion
- Female
- Breast cancer with planned ALND
- postmenopausal or use of contraceptives
- good general health condition
- read and understand Danish
Exclusion
- Pregnant, breastfeeding it wishing to conceive with the next year
- 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
Key Trial Info
Start Date :
February 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04390685
Start Date
February 26 2020
End Date
September 1 2022
Last Update
June 25 2021
Active Locations (3)
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1
Sydvestjysk Sygehus
Esbjerg, Denmark, 6700
2
Department of Plastic and Reconstructive Surgery
Odense, Denmark, 5000
3
Sygehus Lillebælt Vejle
Vejle, Denmark, 7100