Topical Tacrolimus for Breast Cancer-related Lymphedema

Phase 3Enrolling By InvitationNCT06306274

Odense University Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lymphedema

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age over 18 years * BCRL ISL stage I or II * Pitting edema * Postmenopausal or use of Contraceptive drugs * Healthy opposite arm * L-Dex score over 10 Exclusion Criteria: * Pregnant, breast-feeding, or aiming to conceive within the next year * Bilateral breast cancer * Contralateral lymphadenectomy * Allergy to tacrolimus, macrolides, or iodine * Pacemaker * Known kidney or liver disease

Locations (3)

Odense University Hospital

Odense, Denmark

Zealand University Hospital

Roskilde, Denmark

Lillebaelt Hospital

Vejle, Denmark

Outcomes

Primary Outcomes

Lymphedema volume

Change in lymphedema volume (volume of lymphedema arm - volume of healty arm)

Time frame: Baseline to 12 months