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ENROLLING BY INVITATION
NCT06306274
PHASE2/PHASE3

Topical Tacrolimus for Breast Cancer-related Lymphedema

Sponsor: Odense University Hospital

View on ClinicalTrials.gov

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

DRUG

Tacrolimus

Tacrolimus (0,1%) ointment

DRUG

Placebo

Placebo ointment

Locations (3)

Odense University Hospital

Odense, Denmark

Zealand University Hospital

Roskilde, Denmark

Lillebaelt Hospital

Vejle, Denmark