Tacrolimus as Treatment of Breast Cancer-Related Lymphedema

Odense University Hospital0 个研究点目标入组 20 人开始时间: 2020年4月1日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•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

•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

发起方