Arm Measurements, Bioelectric Impedance Analysis, and Collection of Breast Tissue in Studying Lymphedema in Patients with Breast Cancer Undergoing Axillary Lymph Node Dissection

PRIMARY OBJECTIVES:

I. To prospectively determine the incidence of upper extremity lymphedema after axillary lymph node dissection (ALND) using rigorous measurement protocols.

II. To evaluate the role of inflammatory biomarkers, as well as traditional patient and treatment factors, in the pathogenesis of lymphedema.

III. To study the cellular mechanisms that regulate the increased risk of lymphedema development observed in Black women treated with ALND.

SECONDARY OBJECTIVE:

I. To investigate the association between patient-reported symptoms of lymphedema and the presence of lymphedema based on volumetric arm measurements in order to define an optimal threshold for intervention.

EXPLORATORY OBJECTIVES:

I. To determine the correlation between relative volume change measured by perometry, arm volume calculated using circumferential arm measurements and impedance ratio measured by bioimpedance.

II. To describe the trajectory of quality-of-life scores over the study period and in the year following lymphedema diagnosis.

III. To assess the relationship between body mass index (BMI) and the presence of inflammatory biomarkers in the tissue.

IV. To prospectively determine the incidence of upper extremity lymphedema after SLNB, and assess the effect of race and ethnicity, as well as neoadjuvant chemotherapy, on lymphedema risk.

V. To correlate baseline inflammatory status and cytokine levels with risk of developing lymphedema in white versus (vs.) black patients.

VI. To identify serum biomarkers of lymphedema.

OUTLINE:

Patients undergo perometry, circumferential arm measurements, and bioelectrical impedance analysis at baseline, and then every 6 months for up to 3 years. Patients diagnosed with lymphedema 13-18 months after ALND undergo additional perometry, circumferential arm measurements, and bioelectrical impedance analysis at 30 months. Patients diagnosed with lymphedema >= 19 months after ALND undergo additional perometry, circumferential arm measurements, and bioelectrical impedance analysis at 30 and 36 months. Patients who have not yet developed lymphedema by 24 months, undergo an additional measurement at 36 months. Patients diagnosed with lymphedema at 36 months undergo measurements at 42 and 48 months. Patients also undergo collection of breast tissue for the evaluation of the presence of crown-like structures of the breast (CLS-B) at the time of ALND. Additionally, patients may undergo blood sample collection preoperatively and at 12-24 months postoperative.

After completion of study, patients are followed up for up to 4 years.