Prevention of Breast Cancer-related Lymphedma With Tacrolimus (BCRL-TACRO)

Odense University Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Lymphedema

Treatments: Drug: Tacrolimus ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT04390685

S-20180134

2018-003416-50 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Tacrolimus ointment

Experimental group

Description:

Apply whole arm, in a thin layer, once daily for one year

Treatment:

Drug: Tacrolimus ointment

Control

No Intervention group