Study Results
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Basic Information
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RECRUITING
1250 participants
OBSERVATIONAL
2016-04-30
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients who consent for ALND
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.
Bilateral 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.
Body 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.
Quality of Life Questionnaire
Patients treated with SLNB alone
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
Bilateral 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.
Body 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.
Quality of Life Questionnaire
ALND Translational Study Patients
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.
Bilateral 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.
Body 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.
Quality of Life Questionnaire
Blood 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.
Interventions
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Bilateral 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.
Body 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.
Quality of Life Questionnaire
Blood 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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Andrea Barrio, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, United States
Countries
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Central Contacts
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Andrea Barrio, MD
Role: CONTACT
Babak Mehrara, MD
Role: CONTACT
Facility Contacts
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Andrea Barrio, MD
Role: primary
Andrea Barrio, MD
Role: primary
Andrea Barrio, MD
Role: primary
Andrea Barrio, MD
Role: primary
Andrea Barrio, MD
Role: primary
Andrea Barrio, MD
Role: primary
Babak Mehrara, MD
Role: backup
Andrea Barrio, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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16-220
Identifier Type: -
Identifier Source: org_study_id
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