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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003416-50 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus ointment | Experimental | Apply whole arm, in a thin layer, once daily for one year |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus ointment | Drug | Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lymphedema | Arm size change >= 10% using water displacement | 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydvestjysk Sygehus | Esbjerg | 6700 | Denmark | |||
| Department of Plastic and Reconstructive Surgery |
all IPD that underlie results in a publication
Starting 1 year after publication
Jens Ahm Sørensens review requests
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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 |
| Odense |
| 5000 |
| Denmark |
| Sygehus Lillebælt Vejle | Vejle | 7100 | Denmark |