Topical Tacrolimus for Breast Cancer-related Lymphedema
- Registration Number
- NCT06306274
- Lead Sponsor
- Odense University Hospital
- Brief Summary
The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are:
* How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life).
* If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 80
- Age over 18 years
- BCRL ISL stage I or II
- Pitting edema
- Postmenopausal or use of Contraceptive drugs
- Healthy opposite arm
- L-Dex score over 10
- Pregnant, breast-feeding, or aiming to conceive within the next year
- Bilateral breast cancer
- Contralateral lymphadenectomy
- Allergy to tacrolimus, macrolides, or iodine
- Pacemaker
- Known kidney or liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Tacrolimus - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Lymphedema volume Baseline to 12 months Change in lymphedema volume (volume of lymphedema arm - volume of healty arm)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Odense University Hospital
🇩🇰Odense, Denmark
Zealand University Hospital
🇩🇰Roskilde, Denmark
Lillebaelt Hospital
🇩🇰Vejle, Denmark