Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

January 22, 2020

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Breast Cancer Lymphedema
Interventions
PROCEDURE

Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction

Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction

PROCEDURE

Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction

Current standard treatment at Memorial Sloan Kettering \[MSK\]).

OTHER

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.

OTHER

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

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester (Consent Only), Harrison

11553

Memorial Sloan Kettering Nassau (Consent only), Uniondale

11725

Memorial Sloan Kettering Commack (Consent only), Commack

07920

Memorial Sloan Kettering Basking Ridge (Consent and Followup), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Consent Only), Middletown

07645

Memorial Sloan Kettering Bergen (Consent Only), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT04241341 - Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection | Biotech Hunter | Biotech Hunter