The LYMPH-Trial

Surgical treatment compared to “non-surgical” treatment of chronic lymphedema after breast cancer therapy 

Why are we conducting the LYMPH-Trial?

We are looking for better treatment options for lymphedema after breast cancer therapy.

To date, lymphedema has been treated purely through conservative methods, such as lymphatic drainage, physical exercises, and compression garments. However, this approach only alleviates the symptoms and cannot achieve a lasting improvement. It is costly and must be sustained throughout the rest of the patient's life. 

There are microsurgical operations as a treatment for lymphedema.

Two commonly used surgical techniques around the world, called “Lymphovenous Anastomosis (LVA)” and “Vascularised Lymph Node Transplantation (VLNT)” are used to improve the drainage of lymphatic fluid. These procedures can be combined with surgery to remove body fat (liposuction). Several national and international trials have shown that both techniques are effective. That is, patients undergoing these surgeries reported a decrease of lymphedema in the arm and an improvement in their quality of life. You will find more information about the treatments on this website under “Treating lymphedema”.

We need scientific evidence to ascertain the better treatment for lymphedema. 

Relying solely on individual reports is insufficient. We need clear scientific evidence demonstrating that microsurgical treatment in combination with conservative therapy genuinely improves the quality of life and reduces lymphedema in patients with chronic lymphedema following breast cancer treatment. 

What does the trial aim to achieve?

1

Therapy

We need strong evidence, enabling doctors and health insurance companies to make well-informed decisions about recommending surgery for patients.

2

Quality of life

We want patients who suffer from chronic lymphedema after breast cancer treatment to lead a better life in the long term.

3

Information

We will share the outcomes of our research openly, allowing patients worldwide to access and benefit from the study results.

Who can
participate?

Participants of all genders are welcome in the study if they meet the following criteria:

  • You are over 18 years old.

  • You have been diagnosed with breast cancer.

  • A doctor has confirmed your diagnosis of chronic breast cancer-related lymphedema.

  • You have been undergoing treatment for chronic breast cancer-related lymphedema for a minimum of 3 months. This treatment involves conservative therapy such as lymphatic drainage and compression garments.

  • You have not undergone surgery for the treatment of chronic breast cancer-related lymphedema.

How do we proceed?

If you choose to participate, you will be randomly assigned to one of two groups:

  • Group A will undergo surgery and receive conservative therapy.

  • Group B will continue with conservative therapy alone.
    At the end of the intervention, group B can have surgery if they wish.

The intervention, whether a) surgery and conservative therapy or b) conservative therapy only, spans 15 months. Regular check-ups occur throughout this period. The trial lasts over a total of 10 years, with regular follow-up examinations during the initial 2 years.

LYMPH-Trial procedure

LYMPH Trial procedure

What is unique about the LYMPH-Trial?

1.

We observe the patients and their quality of life for a long period of time, specifically 10 years! This timeframe surpasses the usual observation period after surgery. This allows us to assess whether patients’ conditions improve over time and whether the therapies we implement are effective in the long term.

2.

Patient representatives played a direct role in setting up the study. Moreover, individuals with chronic lymphedema following breast cancer treatment actively participated in defining the study objectives, ensuring their needs and preferences were considered.

3.

The study team is committed to sharing the results openly with everyone. This means patients and caregivers worldwide can benefit from the findings.

Because together we can make the best choices.

I would like to take part in the study, how do I proceed?

I want to know more about the study!

Frequently asked questions

We are happy to answer your questions!