Topical tacrolimus for the amelioration of breast cancer-related lymphedema (TACLE Trial): a study protocol for a randomized, double-blind, placebo-controlled phase II/III trial.
Frederik Gulmark Hansen, Mads Gustaf Jørgensen, Jørn Bo Thomsen, Jens Ahm Sørensen
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引用次数: 0
Abstract
Background: Breast cancer-related lymphedema is a chronic condition affecting 15-30% of breast cancer patients, resulting from treatment-related inflammation and fibrosis primarily mediated by CD4 + T-cells. Tacrolimus, an immunomodulator, has shown efficacy in reducing lymphedema in both animal models and an initial clinical trial. This study aims to validate these findings in a larger cohort, hypothesizing that tacrolimus will reduce lymphedema volume, fibrosis, and fluid retention while improving quality of life.
Methods: This multicenter, double-blinded, randomized placebo-controlled trial will enroll 80 women with breast cancer-related lymphedema stages I and II. Participants will be randomized 1:1 to receive either 0.1% tacrolimus ointment or a placebo ointment for 12 months. Primary outcome will be the change in lymphedema volume measured at baseline, 6 months, and 12 months. Secondary outcomes include quality of life assessed via SF- 36, DASH, and LYMPH-Q Upper Extremity questionnaires; lymphedema index via bioimpedance spectroscopy; lymphatic function and flow via indocyanine green lymphangiography; and skin fibrosis measurement. Assessments will take place at baseline, 3, 6, 9, and 12 months.
Discussion: This trial will provide robust data on the efficacy of topical tacrolimus in reducing BCRL volume and improving patient quality of life. Positive results could establish tacrolimus as a standard treatment for BCRL, potentially enhancing clinical outcomes for affected patients. The findings will also contribute to understanding the role of immunomodulation in lymphedema management.
Trial registration: This trial is registered with the EU Clinical Trials Information System (CTIS) under EU CT Number: 2023-503644 - 13-00 (approved 16.05.2024) and ClinicalTrials.gov under identifier NCT06306274 (registered 12.03.2024).
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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