Clinical Trial

Topical Tacrolimus for Breast Cancer-related Lymphedema

Enrolling by Invitation Phase 2/3
View on ClinicalTrials.gov →
Record status
This record was last updated December 2, 2024 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-03-05.
Status change: Not Yet Recruiting → Enrolling by Invitation 2024-11-27
Trial Details
NCT Number NCT06306274
Lead Sponsor Odense University Hospital
Conditions Lymphedema
Enrollment 80 participants
Start Date 2024-09-09
Primary Completion 2026-03-31 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-02