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Topical Tacrolimus for Breast Cancer-related Lymphedema

StatusEnrolling by Invitation
PhasePhase 2/3
Started
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.

Record History

  1. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of May 1, 2024 to Sep 9, 2024
    • Primary and study completion dates: Nov 30, 2025 to Mar 31, 2026
    • Site contacts updated at 2 of 3 sites
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06306274
Lead Sponsor Odense University Hospital
Conditions
(from sponsor)
Lymphedema
Related terms Lymphedema
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov