Prevention of Breast Cancer-related Lymphedma With Tacrolimus

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Breast Cancer-related Lymphedma With Tacrolimus

Conditions
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Lymphedema

Intervention / Treatment
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* Drug: Tacrolimus ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Breast cancer with planned ALND postmenopausal or use of contraceptives good general health condition read and understand Danish Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus ointment<br>Apply whole arm, in a thin layer, once daily for one year | Drug: Tacrolimus ointment<br>* Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphedema | Arm size change >= 10% using water displacement | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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. | 1 year | 
| Change in lymph drainage. (Odense University Hospital Only). | Change in lymph drainage assessed by indocyanine-green lymphangiography | 1 year |