Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Breast Neoplasms

Lymphedema

Breast Cancer Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

In patients 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 at baseline (prior to surgery), post-operatively (after surgery) \& at scheduled timepoints of 6 months, 12 months, 18 months, \& 24 months after surgery for a total of 2 years. For a patient who is diagnosed with lymphedema at ≥ 13 months after surgery, surveillance will continue for an additional 12 months after \[lymphedema\] diagnosis, \& total surveillance time may exceed 2 years. Height \& weight will be obtained for each patient at baseline \& at each scheduled visit for the purpose of calculating BMI. All patients will complete the ULL-27 (upper limb lymphedema) quality-of-life questionnaire at baseline \& at each scheduled visit.

Study requirements which include arm measurements, height and weight and completion of a questionnaire at a single long-term follow-up timepoint, will be explained to the patient

Patients will also be counseled about blood draws, which will include withdrawal of up to 20 mL of blood. Patients who are eligible and agree to participate will sign a consent form. Arm measurements, height and weight, blood draw (if applicable), and baseline questionnaire will be performed at first contact if possible, or at a follow-up scheduled visit prior to surgery.

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.

Bilateral arm measurements

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.

Body mass index (BMI)

Quality of Life Questionnaire

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.

Blood draw

Andrea Barrio, MD

Babak Mehrara, MD

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.

Lymphedema Surveillance Study

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Lymphedema Surveillance Study	NCT02743858	Breast Cancer Lymphedema	Bilateral arm m... Body mass index... Quality of Life... Blood draw	18 Years -	Memorial Sloan Kettering Cancer Center
Lymphedema Surveillance Study	NCT02743858	Breast Cancer Lymphedema	Bilateral arm m... Body mass index... Quality of Life... Blood draw	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for bilateral arm measurements