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NCT06306274 Clinical Trial

Topical Tacrolimus for Breast Cancer-related Lymphedema

Lymphedema Clinical Trial

Official title:
Topical Tacrolimus for the Amelioration of Breast Cancer-related Lymphedema: a Randomized, Double-blind, Placebo-controlled Phase II/III Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06306274
Other study ID # TACLE trial
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 1, 2024
Est. completion date November 30, 2025

Study information
Verified date March 2024
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date November 30, 2025
Est. primary completion date November 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tacrolimus
Tacrolimus (0,1%) ointment
• Placebo
Placebo ointment

Locations
Country Name City State
Denmark Odense University Hospital Odense
Denmark Zealand University Hospital Roskilde
Denmark Lillebaelt Hospital Vejle

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lymphedema volume Change in lymphedema volume (volume of lymphedema arm - volume of healty arm) Baseline to 12 months
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