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

NCT04241341 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-02-27

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Michelle Coriddi, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04241341 on ClinicalTrials.gov