Topical Tacrolimus for Breast Cancer-related Lymphedema

Odense University Hospital

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Lymphedema

Treatments: Drug: Tacrolimus; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06306274

TACLE trial

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Active

Experimental group

Treatment:

Drug: Tacrolimus

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo