Breast Cancer, Lymphedema
Conditions
Keywords
Lymphedema, Surveillance Program, Axillary Lymph Node Dissection, 16-220
Brief 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.
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.
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 * 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
* 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 MSK
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of incidences of lymphedema | 2 year | 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. |
Countries
United States
Contacts
CONTACTAndrea Barrio, MD
CONTACTBabak Mehrara, MD
PRINCIPAL_INVESTIGATORAndrea Barrio, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed