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Arm Measurements, Bioelectric Impedance Analysis, and Collection of Breast Tissue in Studying Lymphedema in Patients with Breast Cancer Undergoing Axillary Lymph Node Dissection
Trial Status: active
This study collects arm measurements, bioelectrical impedance analysis, and breast tissue for the evaluation of lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Gathering health information over time using arm measurements, bioelectrical impedance analysis, and collection of breast tissue from patients with breast cancer undergoing axillary lymph node dissection may help doctors understand how lymphedema develops.
Inclusion Criteria
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
COHORT 3: Patients who self-identify as Black or White consenting for unilateral ALND or possible ALND will be approached for enrollment onto translational study
Exclusion Criteria
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 Memorial Sloan-Kettering (MSK)
Additional locations may be listed on ClinicalTrials.gov for NCT02743858.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Andrea Veronica Barrio
Phone: 646-888-5117
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Andrea Veronica Barrio
Phone: 646-888-5117
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Andrea Veronica Barrio
Phone: 646-888-5117
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Andrea Veronica Barrio
Phone: 646-888-5117
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Andrea Veronica Barrio
Phone: 646-888-5117
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Andrea Veronica Barrio
Phone: 646-888-5117
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Andrea Veronica Barrio
Phone: 646-888-5117
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
