Prevention of Breast Cancer-related Lymphedma With Tacrolimus

Phase 1

• Conditions: Lymphedema
• Interventions: Drug: Tacrolimus ointment

• Registration Number: NCT04390685
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-26
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-15
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-24
• Last Update Posted: 2021-06-25
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Female
• Breast cancer with planned ALND
• postmenopausal or use of contraceptives
• good general health condition
• read and understand Danish

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus ointment	Tacrolimus ointment	Apply whole arm, in a thin layer, once daily for one year

Primary Outcome Measures

Name	Time	Method
Lymphedema	1 year	Arm size change \>= 10% using water displacement

Secondary Outcome Measures

Name	Time	Method
Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire	1 year	Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.
Change in lymph drainage. (Odense University Hospital Only).	1 year	Change in lymph drainage assessed by indocyanine-green lymphangiography
Change in L-DEX score using bioimpedance (Odense University Hospital Only).	1 year	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.
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire	1 year	Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered
Subjective changes assessed using SF-36 questionnaire (Short form-36)	1 year	Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 0 being the most bothered

Trial Locations

Locations (3)

Sygehus Lillebælt Vejle; 🇩🇰 Vejle, Denmark

Department of Plastic and Reconstructive Surgery; 🇩🇰 Odense, Denmark

Sydvestjysk Sygehus; 🇩🇰 Esbjerg, Denmark