Tacrolimus as Treatment of Breast Cancer-Related Lymphedema

Phase 1

• Conditions: ymphedema; MedDRA version: 20.0Level: LLTClassification code 10025233Term: LymphedemaSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2020-000877-25-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-01
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

•Female
•Lymphedema diagnosis as a result of BC treatment
•Significant pitting edema
•Grade I-II lymphedema
•Age between 30-65 years
•Postmenopausal (absence/lack of menstruation in at least 12 consecutive months) or continuously usage of contraceptive drugs (Spiral, birth-control pills, implant, transdermal patches, vaginal ring or depot injection). Contraceptive drugs must be used throughout the project and at least three weeks subsequent to the ending of the project (last application of the ointment)
•Clinically good general condition
•No lymphedema in the opposite arm (Normal arm)
•Understands the purpose of the study and gives written consent to participate
•Can read and understand the Danish language

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

•Pregnant, breast-feeding or with wish of pregnancy within the next year.
•Bilateral BC
•Grade 0, III or IV lymphedema
•Known allergies for Tacrolimus or any other macrolide.
•Removal of lymph nodes in the opposite armpit
•Suffers from psychiatric disorders that may affect the participation in the project
•Reduced kidney or liver function
•Defect skin-barrier
•Diagnosed immunodeficiency

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of Tacrolimus treatment on breast cancer-related lymphedema and how it influences quality of life in patients.;Secondary Objective: Not applicable;Primary end point(s): Armvolume ;Timepoint(s) of evaluation of this end point: 12 months follow-up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Bioimpedance<br>Lympgangiography<br>Patient-reported outcome measures (questionnaires)<br>;Timepoint(s) of evaluation of this end point: 12 months follow-up