Topical Tacrolimus for Breast Cancer-related Lymphedema

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.

Timeline

Start

2024-09-09

Primary completion

2026-03-31

Completion

2026-03-31

Publications

• Hansen FG, Jorgensen MG, Thomsen JB, Sorensen JA. Topical tacrolimus for the amelioration of breast cancer-related lymphedema (TACLE Trial): a study protocol for a randomized, double-blind, placebo-controlled phase II/III trial. Trials. 2025 Apr 8;26(1):127. doi: 10.1186/s13063-025-08829-3.

Drugs

Indications