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
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema

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