Topical Tacrolimus for Breast Cancer-related Lymphedema
Topical Tacrolimus for the Amelioration of Breast Cancer-related Lymphedema: a Randomized, Double-blind, Placebo-controlled Phase II/III Trial
1 other identifier
interventional
80
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2024
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedStudy Start
First participant enrolled
September 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedDecember 2, 2024
November 1, 2024
1.6 years
February 27, 2024
November 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Lymphedema volume
Change in lymphedema volume (volume of lymphedema arm - volume of healty arm)
Baseline to 12 months
Study Arms (2)
Active
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Odense University Hospital
Odense, 5000, Denmark
Zealand University Hospital
Roskilde, 4000, Denmark
Lillebaelt Hospital
Vejle, 4000, Denmark
Related Publications (1)
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: 40200322DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2024
First Posted
March 12, 2024
Study Start
September 9, 2024
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
December 2, 2024
Record last verified: 2024-11