Topical tacrolimus for the amelioration of breast cancer-related lymphedema: a randomized, double-blind, placebo-controlled phase II/III trial

The objective of this trial is to evaluate and confirm the previously observed effect of topical tacrolimus on stage I and II breast cancer-related lymphedema (BCRL). Specifically, we aim to compare the impact of tacrolimus ointment to a placebo ointment on various parameters including lymphedema volume, health-related quality of life (HRQoL), lymphatic flow and function, skin fibrosis, and excess water accumulation in the affected limb. The primary endpoint, assessed at the 12-month follow-up, focuses on achieving a minimum of 10% reduction in lymphedema volume. We hypothesize that this volume reduction will lead to a significant improvement in both subjective and objective symptoms associated with lymphedema. Additionally, we anticipate that patients may experience a reduction in the need for other concomitant lymphedema treatment modalities.