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

Study Overview
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Brief Summary
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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
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A Randomized Controlled Trial: Does Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection

Conditions
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Breast Cancer Lymphedema

Intervention / Treatment
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* Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
* Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction
* Other: quality-of-life questionnaires
* Other: measured by arm volume


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to one of two groups: ALND with ILR (intervention group) and ALND without ILR (control group; current standard treatment at Memorial Sloan Kettering [MSK]).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: axillary lymph node dissection with ILR<br> | Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction<br>* Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction<br>Other: quality-of-life questionnaires<br>* 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.<br>Other: measured by arm volume<br>* 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<br>|
| Active Comparator: axillary lymph node dissection (ALND) without ILR<br> | Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction<br>* Current standard treatment at Memorial Sloan Kettering [MSK]).<br>Other: quality-of-life questionnaires<br>* 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.<br>Other: measured by arm volume<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Axillary Lymph Node Dissection, Lymphatic Reconstruction, 20-021