Short summary

This multicenter, double-blinded, randomized placebo-controlled trial aim to evaluate the efficacy of topical tacrolimus in treating breast cancer-related lymphedema (BCRL). The primary outcome is the change in lymphedema volume, with secondary outcomes including quality of life assessments, lymphedema-index, lymphatic function, and skin fibrosis. The trial will provide robust data on tacrolimus's effectiveness, potentially establishing it as a standard treatment

Rationale

Breast cancer-related lymphedema (BCRL) is a chronic consequence of breast cancer treatment, affecting 15-30% of patients. CD4+ T-cells contribute to BCRL pathogenesis by promoting inflammation and fibrosis. Tacrolimus, an immunomodulator, has shown promise in reducing lymphedema in prelinical trials. A subsequent trial on 18 BCRL patients demonstrated significant volume reduction, improved fluid balance, and increased quality of life. A randomized placebo-controlled trial is proposed to further validate these findings, hypothesizing that tacrolimus reduces lymphedema volume, fibrosis, and fluid retention while enhancing quality of life. This trial aims to validate the efficacy of topical tacrolimus for BCRL stages I and II. It compares tacrolimus ointment to a placebo, evaluating lymphedema volume, HRQoL, lymphatic flow, skin fibrosis, and limb water retention. Primary assessment occurs at 12-month follow-up.

Description of the cohort

The population consists of women aged >18 years with BCRL ISL stage I or II. Subjects must be postmenopausal or have a continuous use of contraceptive drugs and have a normal liver and kidney function. Furthermore, they must have a healthy contralateral arm with no previous lymphadenectomy. They must not have allergy to tacrolimus, macrolides, iodine or have a pacemaker implanted.

Data and biological material

demografic, diagnosis, questionnaire data, data from the patient journal

Collaborating researchers and departments

Department of Plastic Surgery, Vejle Hospital

• Tine Engberg Damsgaard

Roskilde Hospital

• Michael Rose

Publications associated with the project

Gulmark Hansen FC, Jørgensen MG, Sørensen JA. Treatment of Breast Cancer-Related Lymphedema With Topical Tacrolimus: A Prospective, Open-Label, Single-Arm, Phase II Pilot Trial. J Breast Cancer. 2023;26.