Immediate Lymphatic Reconstruction to prevent breast cancer–related lymphedema

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 is a randomized, blinded trial enrolling high-risk women identified by a multidisciplinary tumor board who are undergoing or likely to require axillary lymph node dissection. Participants undergo baseline lymphedema screening with bioimpedance spectroscopy, circumferential limb measurements, and 3D infrared perometry, then are randomized to ILR performed at the time of ALND or to no ILR. Surgery uses RAM to identify lymphatic channels and a microvascular lymphatic-to-venous bypass is performed when suitable lymphatics and veins are found. The study will compare incidence of breast cancer–related lymphedema, safety outcomes, and patient-reported quality of life between the two arms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients consenting for unilateral ALND \[prior history of sentinel lymph node biopsy (SLNBx) allowed if \<6 months from consent\]
* Patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon
* Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery
* Female breast cancer patients 18-75 years of age (inclusive)

Exclusion Criteria:

* • Male breast cancer patients

  * Non-English speaking participants
  * Female breast cancer patients with axillary recurrence
  * Female breast cancer patients who have a history of ALND
  * Female patients requiring bilateral ALND for the treatment of their breast cancer
  * Female breast patients treated with SLNBx only
  * Primary lymphedema of the affected upper limb
  * Secondary lymphedema of the affected limb prior to the lymphadenectomy
  * Radiotherapy at the axilla before the study / surgery
  * Life expectancy \< 2 years for any reason
  * Pregnancy or nursing
  * Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
  * Severe psychiatric disease
  * Distant metastases at the time of preoperative screening

Where it's running

• Tampa General Hospital
  Tampa, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: NIcholas Panetta, MD
• Email: panetta@usf.edu
• Phone: 8134868073

Similar studies

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

• Axillary Web Syndrome after Breast Cancer Surgery: Incidence, Risk Factors, and Outcomes

  This study tests how often AWS occurs after breast cancer surgery and what factors make it more likely, using a forward-looking approach in women undergoing SLNB or ALND.

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• Screening for Breast Cancer-Related Lymphedema in Targeted Therapy

  This study tests whether targeted breast cancer therapies are linked to lymphedema by tracking arm volume and symptoms in women undergoing treatment.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT05142800

• 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

• Kinesio taping for chronic breast and truncal oedema after breast cancer treatment

  This trial tests whether adding kinesio tape to standard decongestive lymphatic therapy helps women with persistent (more than 6 months) breast or truncal swelling after breast cancer treatment.

  Recruiting at 4 sites Universiteit Antwerpen · Antwerp and 3 other locations · NCT07080476

• Effects of physiotherapy on sleep and quality of life in women with lymphedema after breast cancer

  This study is testing whether special physiotherapy can help women with lymphedema after breast cancer feel better and sleep more soundly.

  Recruiting Abant Izzet Baysal University · Bolu and 1 other locations · NCT06697158

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.