Comparing surgical and conservative treatments for chronic lymphedema after breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate whether lymphatic surgery improves quality of life for patients with chronic breast cancer-related lymphedema compared to conservative treatment alone. Participants will be randomly assigned to receive either surgical intervention or conservative complex physical decongestion therapy, which includes manual lymphatic drainage and compression. The effectiveness of these approaches will be assessed using a specific quality of life questionnaire 15 months after randomization. This multicentric randomized controlled trial seeks to provide evidence for the most effective treatment options for this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent.
* Patients ≥ 18 years of age.
* Former diagnosis of breast cancer.
* Clinical diagnosis of chronic Breast Cancer-Related Lymphedema (BCRL) (persisting for more than 3 months) classified as ≥ Stage 1, according to ISL.
* Minimum of 3 months Conservative Complex Physical Decongestion Therapy.
* Ability to complete the QoL questionnaires.
* Willingness to undergo surgery.

Exclusion Criteria:

* No indication for lymphatic surgery according to clinical judgment of the treating surgeon (individual reasons will be specifically documented).
* Primary congenital Lymphedema or non-BCRL.
* Previous surgical BCRL treatment on the side intended for intervention.

Where it's running

• Harvard Medical School
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Washington University School of Medicine in St. Louis
  St Louis, Missouri, United States Recruiting
• University Clinics St.Pölten
  Sankt Pölten, Lower Austria, Austria Recruiting
• Krankenhaus Göttlicher Heiland GmbH
  Vienna, State of Vienna, Austria Recruiting
• Brussels University Hospital
  Brussels, Jette, Belgium Recruiting

Study contacts

• Principal investigator: Elisabeth Kappos, Prof. Dr. — University Hospital, Basel, Switzerland
• Study coordinator: Elisabeth Kappos, Prof. Dr.
• Email: elisabeth.kappos@usb.ch
• Phone: +41 61 328 62 54

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gentle Touch therapy for arm lymphedema after breast cancer surgery

  We will test whether adding Gentle Touch lymphatic drainage to usual rehabilitation reduces arm swelling in women aged 30–75 with breast cancer–related lymphedema.

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• Surgery to prevent lymphedema in breast cancer patients

  This study is testing whether a special surgery can help prevent lymphedema in breast cancer patients who are having their lymph nodes removed.

  Recruiting University Hospital, Ghent · Ghent, Oost-Vlaanderen · NCT05601037

• LYMPHA procedure to prevent arm lymphedema after axillary lymph node removal

  This trial will try adding the LYMPHA lymphatic reconstruction at the time of axillary lymph node removal to see if it lowers the risk of lymphedema in adults having lymphadenectomy for breast cancer.

  Recruiting Stanford University · San Francisco, California · NCT05366699

• Dayspring wearable compression for breast cancer–related arm lymphedema after lymphatic surgery

  This study will test whether the Dayspring wearable compression system helps move lymph and reduce arm swelling in adults with breast cancer–related lymphedema after lymphatic surgery.

  Recruiting Koya Medical, Inc. · Palo Alto, California · NCT04888975

• ESWT added to standard lymphedema care for breast cancer patients

  This study tests whether adding extracorporeal shock wave therapy to standard lymphedema care helps women with unilateral Stage II breast cancer–related swelling.

  Recruiting Ankara City Hospital Bilkent · Ankara · NCT07854262

• Pneumatic compression versus manual lymph drainage as part of decongestive care for breast cancer–related lymphedema

  This study tests whether adding or replacing manual lymph drainage with intermittent pneumatic compression helps women with unilateral breast cancer–related arm lymphedema.

  Recruiting Pamukkale University · Denizli · NCT07154043

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.