NCT06306274

Topical Tacrolimus for Breast Cancer-related Lymphedema

Topical Tacrolimus for the Amelioration of Breast Cancer-related Lymphedema: a Randomized, Double-blind, Placebo-controlled Phase II/III Trial

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lymphedema

Interventions

Type	Name	Description
DRUG	Tacrolimus	Tacrolimus (0,1%) ointment
DRUG	Placebo	Placebo ointment

Timeline

• Start date: 2024-09-09
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-03-12
• Last updated: 2024-12-02

Locations

3 sites across 1 country: Denmark