Prevention of Breast Cancer-related Lymphedma With Tacrolimus

Odense University Hospital3 sites in 1 country60 target enrollmentFebruary 26, 2020

ConditionsLymphedema

InterventionsTacrolimus ointment

DrugsTacrolimus ointment

Overview

Phase: Phase 1
Intervention: Tacrolimus ointment
Conditions: Lymphedema
Sponsor: Odense University Hospital
Enrollment: 60
Locations: 3
Primary Endpoint: Lymphedema
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Tacrolimus ointment may prevent lymphedema by inhibition of CD4+T cells.

Registry

clinicaltrials.gov

Start Date

February 26, 2020

End Date

September 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Odense University Hospital

Responsible Party

Principal Investigator

Mads Gustaf Jørgensen

Medical doctor, ph.d.-student.

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

•Breast cancer with planned ALND
•postmenopausal or use of contraceptives
•good general health condition
•read and understand Danish

Exclusion Criteria

•Pregnant, breastfeeding it wishing to conceive with the next year
•bilateral breast cancer
•known allergy to tacrolimus or macrolides
•known lymphedema
•other malignant disease apart from keratinocyte cancer
•in medical treatment for diabetes mellitus
•known psychiatric condition which may influence participation
•known renal or hepatic function

Arms & Interventions

Tacrolimus ointment

Apply whole arm, in a thin layer, once daily for one year

Intervention: Tacrolimus ointment

Outcomes

Primary Outcomes

Lymphedema

Time Frame: 1 year

Arm size change \>= 10% using water displacement

Secondary Outcomes

Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire(1 year)
Change in lymph drainage. (Odense University Hospital Only).(1 year)
Change in L-DEX score using bioimpedance (Odense University Hospital Only).(1 year)
Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire(1 year)
Subjective changes assessed using SF-36 questionnaire (Short form-36)(1 year)