Tacrolimus as Treatment of Breast Cancer-Related Lymphedema

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000877-25-DK

Enrollment

Registered

2020-04-01

Start date

2020-05-27

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema MedDRA version: 20.0 Level: LLT Classification code 10025233 Term: Lymphedema System Organ Class: 100000004866

Interventions

Trade Name: Protopic 0.1% Product Name: Tacrolimus Pharmaceutical Form: Ointment INN or Proposed INN: Tacrolimus monohydrate Other descriptive name: TACROLIMUS MONOHYDRATE Concentration unit: mg/g mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Female • Lymphedema diagnosis as a result of BC treatment • Significant pitting edema • Grade I-II lymphedema • Age between 30-65 years • Postmenopausal (absence/lack of menstruation in at least 12 consecutive months) or continuously usage of contraceptive drugs (Spiral, birth-control pills, implant, transdermal patches, vaginal ring or depot injection). Contraceptive drugs must be used throughout the project and at least three weeks subsequent to the ending of the project (last application of the ointment) • Clinically good general condition • No lymphedema in the opposite arm (Normal arm) • Understands the purpose of the study and gives written consent to participate • Can read and understand the Danish language Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: • Pregnant, breast-feeding or with wish of pregnancy within the next year. • Bilateral BC • Grade 0, III or IV lymphedema • Known allergies for Tacrolimus or any other macrolide. • Removal of lymph nodes in the opposite armpit • Suffers from psychiatric disorders that may affect the participation in the project • Reduced kidney or liver function • Defect skin-barrier • Diagnosed immunodeficiency

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of Tacrolimus treatment on breast cancer-related lymphedema and how it influences quality of life in patients.;Secondary Objective: Not applicable;Primary end point(s): Armvolume ;Timepoint(s) of evaluation of this end point: 12 months follow-up	—

Secondary

Measure	Time frame
Secondary end point(s): Bioimpedance Lympgangiography Patient-reported outcome measures (questionnaires) ;Timepoint(s) of evaluation of this end point: 12 months follow-up	—

Countries

Denmark

Contacts

Public ContactDept. of Plastic Surgery

Odense University Hospital

Jens.sorensen@rsyd.dk004565412436

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026