RecruitingNCT02743858

Lymphedema Surveillance Study

A Prospective Surveillance Program for Assessment and Treatment of Breast Cancer-Related Lymphedema After Axillary Lymph Node Dissection

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

1,250 participants

Start Date

Apr 1, 2016

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Lymphedema

Summary

This study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. The investigators also want to look for reasons why some women get lymphedema and others don't. Specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a woman's risk for lymphedema. The investigators will also ask the patient to answer questions to see how much their quality of life is affected by lymphedema, and whether this study can help women by detecting lymphedema earlier.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking women who have had lymph nodes removed from their armpit during breast cancer surgery, to monitor for lymphedema — a condition where the arm swells because fluid cannot drain properly — and to understand who is most at risk. **You may be eligible if...** - You are a woman over 18 with breast cancer - You are scheduled for or have had lymph nodes removed from one armpit (axillary lymph node dissection) - You may also be eligible if you are scheduled for a sentinel lymph node biopsy that may lead to full lymph node removal - Black or White women undergoing full lymph node removal may be approached for an additional related sub-study **You may NOT be eligible if...** - You are male - You have had prior lymph node surgery or previous lymphedema in the same arm - Your sentinel node biopsy did not proceed to full lymph node removal - You have had prior surgery or radiation to both armpits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBilateral arm measurements

Pts treated with ALND, bilateral arm measurements will be obtained using the Perometer (Model 350 NT Perometer, Per-System) circumferential arm measurements with elastic tape taken at 4-cm intervals from the wrist to the shoulder \& the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements. Measurements will be performed before surgery, post-operatively \& at timepoints of 6,12,18, \& 24 months after surgery for 2 years will be obtained using the Perometer (Model 350 NT Perometer, Per-System) for bioimpedance measurements. Pts who have not yet developed lymphedema by 2 years, an additional measurement at approx 3 years post-surgery will be performed. If pt is diag with lymphedema at the 3-year visit, she will be asked to continue on study for an additional year. Pts treated with SLNB alone, following re-consent, a long-term follow-up volumetric arm measurement will be obtained using the perometer \& circumferential arm measurements at a minimum of 2 years post-surgery.

OTHERBody mass index (BMI)

Height and weight will be obtained for each patient at baseline and at each scheduled visit for the purpose of calculating BMI. BMI will be correlated with the presence of inflammatory biomarkers in the tissue, as well as with lymphedema development.

BEHAVIORALQuality of Life Questionnaire

OTHERBlood draw

Patients enrolled in the translational study (Cohort 3) will undergo blood draws for serum collection preoperatively and 12-24 months postoperatively to test for FGF2, IL4, IL10, TGFB, Leptin, IL6, and CRP. At both timepoints, up to 20 mL of blood will be collected.