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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection
Sydvestjysk Sygehus
Esbjerg, Denmark
Department of Plastic and Reconstructive Surgery
Odense, Denmark
Sygehus Lillebælt Vejle
Vejle, Denmark
Lymphedema
Arm size change \>= 10% using water displacement
Time frame: 1 year
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire
Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.
Time frame: 1 year
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire
Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered
Time frame: 1 year
Subjective changes assessed using SF-36 questionnaire (Short form-36)
Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 0 being the most bothered
Time frame: 1 year
Change in L-DEX score using bioimpedance (Odense University Hospital Only).
Change in L-DEX score of lymphedema arm derived from bioimpedance. Higher values mean more fluid in the lymphedema arm compared to the healthy arm.
Time frame: 1 year
Change in lymph drainage. (Odense University Hospital Only).
Change in lymph drainage assessed by indocyanine-green lymphangiography
Time frame: 1 year
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