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Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection
Sponsor: Memorial Sloan Kettering Cancer Center
Summary
The researchers are doing this study to see if having immediate lymphatic reconstruction after axillary lymph node dissection (ALND) can decrease the development of lymphedema, a side effect of ALND. Other purposes of the study include: Comparing the approach of immediate lymphatic reconstruction after ALND with the approach of ALND alone Looking at whether having immediate lymphatic reconstruction after ALND improves a person's quality of life Seeing if adding standard of care radiation therapy to either study approach (immediate lymphatic reconstruction after ALND or ALND alone) has an effect on development of lymphedema
Official title: A Randomized Controlled Trial: Does Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2020-01-22
Completion Date
2027-01
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction
Current standard treatment at Memorial Sloan Kettering \[MSK\]).
quality-of-life questionnaires
Four validated patient reported outcome measures (PROMs): the Upper Limb Lymphedema-27 (ULL-27), the Quality of Life Measure for Limb Lymphedema (LYMQOL), the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Anxiety Inventory (BAI). Study participants will undergo standard lymphedema measurements and quality-of-life questionnaires at baseline before ALND and postoperatively at 6 weeks (+/- 30 days) and at 6, 12, 18, and 24 months (+/- 30 days). If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them.
measured by arm volume
Bilateral arm volumes will be measured with sequential circumferential measurements with the truncated cone formula. If a patient cannot return to Manhattan for these assessments but is seen by a lymphedema therapist in a regional location or at an institution outside of MSK as part of their routine cancer treatment, this data can be used in the final analysis
Locations (7)
Memorial Sloan Kettering Basking Ridge (Consent and Followup)
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