Topical Tacrolimus for Breast Cancer-related Lymphedema
NCT ID: NCT06306274
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2024-09-09
2026-03-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active
Tacrolimus
Tacrolimus (0,1%) ointment
Placebo
Placebo
Placebo ointment
Interventions
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Tacrolimus
Tacrolimus (0,1%) ointment
Placebo
Placebo ointment
Eligibility Criteria
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Inclusion Criteria
* BCRL ISL stage I or II
* Pitting edema
* Postmenopausal or use of Contraceptive drugs
* Healthy opposite arm
* L-Dex score over 10
Exclusion Criteria
* Bilateral breast cancer
* Contralateral lymphadenectomy
* Allergy to tacrolimus, macrolides, or iodine
* Pacemaker
* Known kidney or liver disease
18 Years
FEMALE
Yes
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Locations
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Odense University Hospital
Odense, , Denmark
Zealand University Hospital
Roskilde, , Denmark
Lillebaelt Hospital
Vejle, , Denmark
Countries
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References
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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.
Other Identifiers
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TACLE trial
Identifier Type: -
Identifier Source: org_study_id