EUCTR2020-000877-25-DKActive, not recruitingPhase 1
Tacrolimus as Treatment of Breast Cancer-Related Lymphedema
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Odense University Hospital
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Lymphedema diagnosis as a result of BC treatment
- •Significant pitting edema
- •Grade I-II lymphedema
- •Age between 30-65 years
- •Postmenopausal (absence/lack of menstruation in at least 12 consecutive months) or continuously usage of contraceptive drugs (Spiral, birth-control pills, implant, transdermal patches, vaginal ring or depot injection). Contraceptive drugs must be used throughout the project and at least three weeks subsequent to the ending of the project (last application of the ointment)
- •Clinically good general condition
- •No lymphedema in the opposite arm (Normal arm)
- •Understands the purpose of the study and gives written consent to participate
- •Can read and understand the Danish language
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
- •Pregnant, breast-feeding or with wish of pregnancy within the next year.
- •Bilateral BC
- •Grade 0, III or IV lymphedema
- •Known allergies for Tacrolimus or any other macrolide.
- •Removal of lymph nodes in the opposite armpit
- •Suffers from psychiatric disorders that may affect the participation in the project
- •Reduced kidney or liver function
- •Defect skin-barrier
- •Diagnosed immunodeficiency
Investigators
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