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Topical Tacrolimus for Breast Cancer-related Lymphedema
Sponsor: Odense University Hospital
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.
Official title: Topical Tacrolimus for the Amelioration of Breast Cancer-related Lymphedema: a Randomized, Double-blind, Placebo-controlled Phase II/III Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-09-09
Completion Date
2026-03-31
Last Updated
2024-12-02
Healthy Volunteers
Yes
Conditions
Interventions
Tacrolimus
Tacrolimus (0,1%) ointment
Placebo
Placebo ointment
Locations (3)
Odense University Hospital
Odense, Denmark
Zealand University Hospital
Roskilde, Denmark
Lillebaelt Hospital
Vejle, Denmark