Lymphedema
Conditions
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.
Interventions
DRUGTacrolimus
Tacrolimus (0,1%) ointment
DRUGPlacebo
Placebo ointment
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
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 * Known kidney or liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymphedema volume | Baseline to 12 months | Change in lymphedema volume (volume of lymphedema arm - volume of healty arm) |
Countries
Denmark
Outcome results
None listed