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Topical tacrolimus for the amelioration of breast cancer-related lymphedema: a randomized, double-blind, placebo-controlled phase II/III trial
EU CTIS ID: 2023-503644-13-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 18 years
- BCRL ISL stage I or II
- Pitting edema
- Postmenopausal or use of Contraceptive drugs
- Healthy opposite arm
- L-Dex score>10
You likely can't join if
- Pregnant, breast-feeding, or aiming to conceive within the next year
- Bilateral breast cancer
- Contralateral lymphadenectomy
- Allergy to tacrolimus, macrolides, or iodine
- Pacemaker implant
- Known kidney or liver disease
See the full eligibility criteria
- Age > 18 years
- BCRL ISL stage I or II
- Pitting edema
- Postmenopausal or use of Contraceptive drugs
- Healthy opposite arm
- L-Dex score>10
- Lymphedema volume >10% of healthy arm
- Comprehension of Danish
- Female
- Pregnant, breast-feeding, or aiming to conceive within the next year
- Bilateral breast cancer
- Contralateral lymphadenectomy
- Allergy to tacrolimus, macrolides, or iodine
- Pacemaker implant
- Known kidney or liver disease
- Defect skin-barrier on the affected arm
- Diagnosed immunodeficiency or treated with immunosuppressive medicine
- No previous surgical treatment for lymphedema
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.