RecruitingNAINTERVENTIONAL

The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema

This study, called The LYMPH Trial, is investigating the best way to treat ongoing arm swelling (lymphoedema) that can happen after breast cancer. Currently, the main treatment involves gentle massage, compression bandages, and skincare. While helpful, it often doesn't stop the swelling from getting worse. Researchers are looking into two types of surgery that could fix the root cause of the swelling rather than just managing symptoms. They want to find out if these surgeries improve daily life more than the standard non-surgical approach. The study will compare patients who have surgery to those who continue with the usual massage and compression treatment to see which offers a better quality of life after about a year.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Basel, Switzerland

Enrolment target

280

Start

14 Jul 2023

Estimated completion

01 Jun 2036

Lymphedema, Breast Cancer

What is this study about?

If you've had breast cancer, you might have developed a condition called lymphoedema, which is ongoing swelling, often in your arm. This happens because the system that drains fluid from your body (the lymphatic system) gets damaged. Currently, the main way to manage this is through something called 'complex physical decongestion therapy' (CDT). This involves special massages (manual lymphatic drainage), compression bandages or garments, exercises, and careful skin care. While CDT can help manage the swelling, it often doesn't prevent it from getting worse and usually means lifelong treatment.

Doctors are exploring surgical options that might actually fix the problem causing the swelling, rather than just treating the symptoms. These surgeries, like lymphovenous anastomosis (LVA) or vascularised lymph node transfer (VLNT), aim to reconnect or replace the damaged parts of your lymphatic system. They've shown promising results in other smaller studies, helping to reduce swelling and improve how people feel and live their daily lives.

However, there hasn't yet been a large, official study comparing these surgeries directly with CDT. This means it can be hard for patients to access these surgeries, as insurance companies sometimes don't cover the costs. This trial aims to gather strong evidence to show if surgery is truly better than CDT alone, so more people can access the most effective treatment for their lymphoedema.

Key takeaways

This study compares surgery with standard care for ongoing arm swelling after breast cancer.
It aims to see if surgery improves your daily life more effectively.
Participation involves being randomly assigned to either surgery or ongoing standard treatment.
The study lasts about 15 months, tracking your quality of life.
It helps build evidence for wider access to effective lymphoedema treatments.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who has had breast cancer and has ongoing arm swelling (lymphoedema) that has lasted for more than three months. This swelling should be at a certain stage (Stage 1 or higher, as defined by medical experts), and you should have already tried the standard gentle massage and compression therapy for at least three months.

You also need to be able to complete questionnaires about your quality of life and be willing to consider having surgery if that's what the study involves for you. Importantly, you'll need to give your permission in writing to take part.

This study is not for you if a surgeon has already decided that surgery isn't suitable for your lymphoedema. It's also not suitable if your lymphoedema is due to a condition you were born with or another reason unrelated to breast cancer. Also, if you've already had surgery for breast cancer-related lymphoedema on the same arm, you won't be able to join this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 or older?
Have you had breast cancer?
Do you have chronic arm swelling (lymphoedema) that's lasted over 3 months?
Have you tried standard massage/compression therapy for at least 3 months?
Are you able and willing to complete questionnaires about your life?
Are you open to having surgery if assigned to that group?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first be randomly placed into one of two groups. One group will continue with the standard gentle massage and compression treatment (conservative care). The other group will have surgery. Being 'randomly placed' means it's like flipping a coin for fairness; you won't get to choose which group you're in.

If you're in the surgery group, you will have a surgical procedure. After surgery, or if you're in the conservative care group, you'll continue with your assigned treatment. Your progress will be tracked for about 15 months after your initial treatment choice. During this time, you'll be asked to complete questionnaires about your quality of life, likely at specific times, to help researchers understand how you're feeling and functioning. The exact number of visits or assessments will be explained by the study team.

Potential risks and benefits

Taking part in this study may offer the benefit of potentially finding a more effective treatment for your lymphoedema, which could significantly improve your quality of life. However, as with any medical treatment, there are potential risks, especially with surgery. The study aims to use surgical techniques known to have low complication rates, but risks associated with surgery can include infection, bleeding, or other surgical complications, which your medical team will discuss with you. There are no direct benefits for those in the conservative treatment arm of the trial, beyond usual care, although their participation will contribute to scientific understanding. You have the right to withdraw from the study at any time without affecting your ongoing medical care.

Locations (36)

Yale School of Medicine
Verified postcode
New Haven, United States· Not yet recruiting
Harvard Medical School
Verified postcode
Boston, United States· Recruiting
Washington University School of Medicine in St. Louis
Verified postcode
St Louis, United States· Recruiting
Mayo Clinic
Verified postcode
Rochester, United States· Not yet recruiting
University Clinics St.Pölten
Verified postcode
Sankt Pölten, Austria· Not yet recruiting
Krankenhaus Göttlicher Heiland GmbH
Verified postcode
Vienna, Austria· Not yet recruiting
Brussels University Hospital
Verified postcode
Brussels, Belgium· Recruiting
University of Ghent
Verified postcode
Ghent, Belgium· Recruiting
Hospital Erasto Gaertner
Verified postcode
Paraná, Brazil· Not yet recruiting
McGill University, Royal Victoria Hospital
Verified postcode
Montreal, Canada· Recruiting
University of British Columbia, Gordon and Leslie Diamond Health Care Centre
Verified postcode
Vancouver, Canada· Recruiting
BG Universitätsklinikum Bergmannsheil Bochum
Verified postcode
Bochum, Germany· Recruiting

Common questions

What is lymphoedema?

Lymphoedema is long-term swelling, often in the arm or leg, that can happen after cancer treatment, like breast cancer surgery, when the body's drainage system (lymphatic system) is damaged.

What is 'conservative treatment'?

Conservative treatment usually involves gentle massage, special compression garments or bandages, skin care, and exercises to manage the swelling and discomfort caused by lymphoedema.

What kind of surgery is being studied?

The study looks at two types of surgery: LVA (lymphovenous anastomosis) which creates tiny bypasses for fluid, and VLNT (vascularised lymph node transfer) which moves healthy lymph nodes to the affected area to help drainage.

Will I have to pay for treatment if I join?

The study aims to establish if surgery is better, which could help with insurance claims. Specific details about costs and insurance coverage should be discussed with the study team and your insurer.

How long does the study last?

Your progress and quality of life will be checked for about 15 months after you start either the surgical or conservative treatment.

How to find out more

Elisabeth Kappos, Prof. Dr.

elisabeth.kappos@usb.ch +41 61 328 62 54 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.