Lymphedema Surveillance Study for Breast Cancer Patients

This observational study is looking at how many women develop lymphedema (swelling caused by fluid buildup) after breast cancer surgery that involves removing lymph nodes from the armpit (axillary lymph node dissection). Researchers also want to understand why some women get lymphedema and others don't. They will measure your arms using a Perometer and L-Dex U400, calculate your Body Mass Index (BMI), and ask you to complete a Quality of Life Questionnaire. Some participants will also have blood drawn before and after surgery to look for certain markers. The study aims to see if detecting inflammation in breast tissue can help predict lymphedema risk and if earlier detection can improve outcomes. This study is for women aged 18 and older who are having breast cancer surgery involving lymph node removal. The main goal is to count how many cases of lymphedema occur over two years.

Study design: This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It aims to enroll 1250 women.
What's involved: You will have arm measurements, height and weight taken at baseline and scheduled visits. You will also complete a Quality of Life Questionnaire. Some participants will have up to 20 mL of blood drawn before surgery and 12-24 months after.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome, the number of lymphedema cases, will be measured at two years.

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

Lymphedema Surveillance Study

Recruiting

Not specifiedAges 18+Observational

Memorial Sloan Kettering Cancer Center

~1,250 participants

Updated 2026-05-07 on ClinicalTrials.gov

What's tested:Bilateral arm measurementsBody mass index (BMI)Quality of Life QuestionnaireBlood draw

At a glance

Recruiting sites

7 of 7 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

number of incidences of lymphedema

Measured over 2 year

Conditions

Breast Cancer

Lymphedema

Where it's being run

7 sites across 2 states

New York4

New Jersey3

Study leadership

Andrea Barrio, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Andrea Barrio, MD

646-888-5117

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Female breast cancer patients over the age of 18

Patients consenting for unilateral axillary lymph node dissection (ALND) (prior history of sentinel lymph node biopsy allowed if \<6 months from consent)

Patients consenting for unilateral sentinel lymph node biopsy (SLNB) and possible ALND are eligible for initial entry into the study, but will become ineligible if ALND is not performed

Initially consented patients, treated with SLNB alone, who were originally considered ineligible to continue on study, will be approached for re-enrollment

Patients who self-identify as Black or White consenting for unilateral ALND or possible ALND will be approached for enrollment onto translational study (Cohort 3)

Exclusion

Male breast cancer patients

Patients consenting for bilateral axillary surgery

Patients with prior history of surgical excision of one or more axillary lymph nodes or SLNB, performed \>6 months from date of consent

Patients with prior history of ALND

Patients with no breast surgery performed at MSK

What this trial measures

number of incidences of lymphedema2 year
as defined by perometry using rigorous measurement protocols. Bilateral arm measurements will be obtained using the Perometer (Model 350 NT Perometer, Per-System) and the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements.

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