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ILR to Prevent Breast Cancer-Related Lymphedema

This study is testing a procedure called Immediate Lymphatic Reconstruction (ILR) to see if it can prevent breast cancer-related lymphedema (BCRL) in women who are having surgery to remove lymph nodes (axillary lymph node dissection or ALND). ILR involves connecting preserved lymphatic channels to nearby veins during surgery. The study aims to find out if ILR reduces the chance of getting BCRL and how it affects your quality of life. You might be able to join if you are a woman between 18 and 75 years old, are having ALND, or are likely to need it. The main goal is to see how many participants develop BCRL 24 months after their ALND surgery. The current recruitment status is unclear.

Study design
This is a randomized controlled trial with a planned enrollment of 98 participants. Participants will be randomly assigned to either receive ILR or not, and you will not know which group you are in.
What's involved
You will undergo screening measurements and then be randomized. If in the intervention group, you will have the ILR procedure during your ALND surgery. Follow-up visits will occur for 24 months after ALND.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after their axillary lymph node dissection (ALND) surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07127003

ILR to Prevent BRCL_MCC 23608

Recruiting
NAAges 18–75InterventionalPrevention
University of South Florida
~98 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:Immediate Lymphatic Reconstruction

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of BCRL at 24-month post follow up visit
Measured over 24 months Post ALND

Conditions

Breast Cancer Lymphedema

Explore related trials

Breast Carcinoma

Where it's being run

3 sites across 1 states
Florida3

Who to contact

NIcholas Panetta, MD
[email protected]
8134868073
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

• 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

What this trial measures

  • Incidence of BCRL at 24-month post follow up visit24 months Post ALND

    Efficacy of ILR will be measured by the incidence of BCRL at the 24 month post follow up visit