Topical Tacrolimus for Breast Cancer-related Lymphedema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tacrolimus, Placebo.
- Who it may be relevant to
- Registry conditions: Lymphedema. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Topical Tacrolimus for the Amelioration of Breast Cancer-related Lymphedema: a Randomized, Double-blind, Placebo-controlled Phase II/III Trial
Overview
The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are: * How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life). * If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months.
Interventions
- Drug Tacrolimus
Tacrolimus (0,1%) ointment - Drug Placebo
Placebo ointment
Primary outcome measures
- Lymphedema volume [Time frame: Baseline to 12 months]
Eligibility criteria
Inclusion criteria
- Age over 18 years
- BCRL ISL stage I or II
- Pitting edema
- Postmenopausal or use of Contraceptive drugs
- Healthy opposite arm
- L-Dex score over 10
Exclusion criteria
- Pregnant, breast-feeding, or aiming to conceive within the next year
- Bilateral breast cancer
- Contralateral lymphadenectomy
- Allergy to tacrolimus, macrolides, or iodine
- Pacemaker
- Known kidney or liver disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Denmark · 3 centers
- Odense University Hospital — Odense
- Zealand University Hospital — Roskilde
- Lillebaelt Hospital — Vejle
Publications
- Hansen FG, Jorgensen MG, Thomsen JB, Sorensen JA. 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. Trials. 2025 Apr 8;26(1):127. doi: 10.1186/s13063-025-08829-3. PMID 40200322
Identifiers
NCT: NCT06306274 · TACLE trial