Topical tacrolimus for the amelioration of breast cancer-related lymphedema: a randomized, double-blind, placebo-controlled phase II/III trial
Phase 1
- Conditions
- Breast cancer-related lymphedemaMedDRA version: 20.0Level: LLTClassification code: 10025233Term: Lymphedema Class: 10047065Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2023-503644-13-00
- Lead Sponsor
- Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Age > 18 years, BCRL ISL stage I or II, Pitting edema, Postmenopausal or use of Contraceptive drugs, Healthy opposite arm, L-Dex score>10, Lymphedema volume >10% of healthy arm, Comprehension of Danish, Female
Exclusion Criteria
Pregnant, breast-feeding, or aiming to conceive within the next year, Bilateral breast cancer, Contralateral lymphadenectomy, Allergy to tacrolimus, macrolides, or iodine, Pacemaker implant, Known kidney or liver disease, Defect skin-barrier on the affected arm, Diagnosed immunodeficiency or treated with immunosuppressive medicine, No previous surgical treatment for lymphedema
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method