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Clinical Trials in Denmark / NCT06306274
Enrolling by invitation Phase 2/3

Topical Tacrolimus for Breast Cancer-related Lymphedema

NCT06306274 · tracked via the Priya Life Science Denmark tracker
Sponsor
Odense University Hospital
Phase
Phase 2/3
Started
2024-09-09
Last updated
2024-12-02

Condition(s) studied

Lymphedema

Investigational drug(s) / intervention(s)

Tacrolimus →Placebo

Tacrolimus: Tacrolimus (0,1%) ointment

Placebo: Placebo ointment

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Odense University Hospital Odense Denmark
Zealand University Hospital Roskilde Denmark
Lillebaelt Hospital Vejle Denmark

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Quantification of Anastomostic Blood Flow With Fluorescence Imaging in Low Anterior Resection for Rectal Cancer Starting soon

Other trials for the same condition

Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost Active, not recruiting
Effect of Lymphovenous Anastomosis on Lower Limb Lymphedema: Pragmatic Randomized Controlled Trial Recruiting
The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema (the LymphEx Study) Recruiting
Lymphaticovenous Anastomosis as Treatment for Lymphedema Active, not recruiting
Lymphovenous Anastomosis for Breast Cancer Lymphedema Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06306274 on ClinicalTrials.gov ↗ ← All trials in Denmark