Topical Tacrolimus for Breast Cancer-related Lymphedema

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.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Odense University Hospital, Odense, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

Tacrolimus (0,1%) ointment

Placebo

Drug

Placebo ointment

Primary outcomes

Lymphedema volume

Time frame: Baseline to 12 months

Change in lymphedema volume (volume of lymphedema arm - volume of healty arm)

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Mar 12, 2024
Registry last updated: Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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