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

Overview

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

Full Title of Study: “A Randomized Controlled Trial: Does Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2026

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

Arms, Groups and Cohorts

  • Experimental: axillary lymph node dissection with ILR
  • Active Comparator: axillary lymph node dissection (ALND) without ILR

Clinical Trial Outcome Measures

Primary Measures

  • the number of patients that had a decrease incidence of lymphedema
    • Time Frame: up to 2 years
    • as measured by arm volume will be a ≥10% increase in arm volume

Participating in This Clinical Trial

Inclusion Criteria

  • Female breast cancer patients 18-75 years of age – Patients consenting for unilateral ALND (prior history of SLNBx allowed if <6 months from consent) OR patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon – Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery Exclusion Criteria:

  • Male breast cancer patients – Non-English speaking participants – Female breast cancer patients with axillary recurrence – Female breast cancer patients who have a history of ALND – Female patients requiring bilateral ALND for the treatment of their breast cancer – Female breast patients treated with SLNBx only

Gender Eligibility: Female

Breast Cancer

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michelle Coriddi, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

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