Ongoing Clinical Trials for Lymphoedema
Currently, there is one ongoing clinical trial focused on lymphoedema, specifically targeting breast cancer-related lymphoedema. This trial is investigating the use of Tacrolimus ointment to reduce swelling and improve quality of life for affected patients. The study is being conducted in Denmark and aims to evaluate whether this topical treatment can achieve meaningful reductions in arm swelling following breast cancer treatment.
Clinical trial locations
Study on Tacrolimus Ointment for Reducing Lymphedema in Breast Cancer Patients
This clinical trial is investigating breast cancer-related lymphoedema, a condition characterised by swelling in the arm due to a buildup of lymph fluid. This often occurs as a consequence of breast cancer treatment, including surgery or radiation therapy. The condition can develop shortly after treatment or even years later, causing the affected arm to feel heavy, tight, or painful. Over time, the skin may thicken and the range of motion may become limited.
Who can participate:
- Women over 18 years old who can understand Danish
- Those with stage I or II breast cancer-related lymphoedema with pitting oedema (when pressing on the swollen area leaves a dent)
- Patients whose lymphoedema volume is more than 10% compared to the healthy arm
- Women who are postmenopausal or using birth control
- Those with an L-Dex score greater than 10, which measures the amount of fluid retention in the body
- Individuals whose opposite arm is healthy
Who cannot participate:
- Men or individuals outside the specified age range
- Those without breast cancer-related lymphoedema
- Individuals considered part of a vulnerable population who may have limited ability to give informed consent
What the trial involves:
The study is testing Tacrolimus Accord 0.1% ointment, a topical medication applied directly to the skin. Tacrolimus is an immunosuppressant that works by reducing inflammation and potentially improving lymphatic function in the affected area. Participants will be randomly assigned to receive either the tacrolimus ointment or a placebo ointment. Neither the participants nor the researchers will know which treatment is being given during the study, ensuring unbiased results.
The treatment phase involves regular application of the assigned ointment to the affected area. Throughout the 12-month trial period, participants will undergo regular assessments to monitor changes in swelling, 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 lymphoedema volume by the end of the study, which could lead to improvements in both symptoms and physical signs of the condition.
The trial is expected to conclude by December 31, 2025, at which point final evaluations will determine whether the treatment is effective in reducing lymphoedema and improving related symptoms.
Summary
Currently, only one clinical trial is actively recruiting patients with lymphoedema. This trial is specifically focused on breast cancer-related lymphoedema and is being conducted in Denmark. The study investigates the potential benefits of Tacrolimus ointment, a topical immunosuppressant, in reducing arm swelling and improving quality of life for affected women. The trial employs a rigorous double-blind, placebo-controlled design to ensure reliable results. If successful, this treatment could offer a new option for managing this chronic condition, potentially reducing the need for more intensive therapies.