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Study on Tacrolimus Ointment for Reducing Lymphedema in Breast Cancer Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying breast cancer-related lymphedema, a condition where swelling occurs in the arm due to a buildup of lymph fluid, often after breast cancer treatment. The study will use a treatment called Tacrolimus Accord 0.1% ointment, which is applied to the skin. This ointment will be compared to a placebo ointment to see if it can help reduce the swelling and improve the quality of life for those affected by this condition.

The purpose of the study is to evaluate the effects of the tacrolimus ointment on various aspects of lymphedema, such as the volume of swelling, the flow and function of the lymphatic system, skin thickening, and the amount of excess water in the affected arm. The study aims to achieve at least a 10% reduction in the volume of lymphedema over a 12-month period, which could lead to improvements in both the symptoms felt by patients and the physical signs of the condition.

Participants in the study will be randomly assigned to receive either the tacrolimus ointment or the placebo ointment. The study will be conducted in a way that neither the participants nor the researchers know which treatment is being given, ensuring unbiased results. The trial will last for up to 12 months, during which the effects of the treatment will be monitored and assessed to determine its effectiveness in managing breast cancer-related lymphedema.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, stage of lymphedema, and health status of the opposite arm.
Participants must be female, over 18 years old, and able to understand Danish.
Step 2
Randomization
Participants are randomly assigned to receive either the tacrolimus ointment or a placebo ointment.
This process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered.
Step 3
Treatment phase
The treatment involves applying the assigned ointment to the affected area.
The ointment is applied cutaneously (on the skin) as per the instructions provided by the study team.
Step 4
Follow-up assessments
Regular assessments are conducted to monitor changes in lymphedema volume, quality of life, lymphatic function, skin condition, and water retention in the limb.
The primary goal is to achieve at least a 10% reduction in lymphedema volume by the 12-month follow-up.
Step 5
Completion of the trial
The trial is expected to conclude by December 31, 2025.
Final evaluations will determine the effectiveness of the treatment in reducing lymphedema and improving related symptoms.

Who can join the trial?

9 criteria

You must be over 18 years old.
You should have **breast cancer-related lymphedema** at stage I or II. Lymphedema is swelling that can happen after breast cancer treatment.
You need to have **pitting edema**, which means when you press on the swollen area, it leaves a dent.
You should be **postmenopausal** (after menopause) or using **contraceptive drugs** (birth control).
Your opposite arm (the one not affected by lymphedema) should be healthy.
Your **L-Dex score** should be greater than 10. This score helps measure the amount of fluid in your body.
The volume of your lymphedema should be more than 10% compared to your healthy arm.
You need to understand Danish.
You must be female.

Who cannot join the trial?

4 criteria

Patients who are not female cannot participate in the study.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, so it's important to check if you fall within it.
Patients who do not have breast cancer-related lymphedema cannot participate. **Lymphedema** is a condition where there is swelling due to a build-up of fluid, often occurring after breast cancer treatment.
Patients who are part of a vulnerable population cannot participate. A **vulnerable population** includes groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Odense University Hospital
Odense, Denmark
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Sygehus Lillebaelt Vejle Sygehus
Vejle, Denmark
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Zealand University Hospital
Koege, Denmark

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Investigated drugs

Tacrolimus: Tacrolimus is an ointment used in this trial to help reduce swelling and improve symptoms in patients with lymphedema related to breast cancer. The study aims to see if applying this ointment can decrease the volume of lymphedema, improve the quality of life, and enhance lymphatic function. The goal is to achieve at least a 10% reduction in swelling, which may also lessen the need for other treatments.

What is already known about the treatment

Tacrolimus – Tacrolimus is administered as a topical ointment and is currently being studied in a clinical trial for its effects on breast cancer-related lymphedema. This medication is primarily used to reduce inflammation and improve lymphatic function in affected areas. It works by inhibiting calcineurin, a protein that activates T-cells, thereby reducing immune response and inflammation. Tacrolimus is classified as an immunosuppressant and is being evaluated for its potential to decrease lymphedema volume and improve quality of life for patients.

Investigated diseases

Breast cancer-related lymphedema – This condition occurs when lymph fluid builds up in the tissues, causing swelling, typically in the arm, after breast cancer treatment. It is a chronic condition that can develop soon after surgery or radiation therapy, or it may appear months or even years later. The swelling is due to a blockage in the lymphatic system, which is part of the immune system. As the condition progresses, the affected area may feel heavy, tight, or painful, and the skin may thicken or harden. Over time, the range of motion in the affected limb may decrease, and there may be an increased risk of infections. Managing the condition involves reducing the swelling and preventing complications.