Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04241341

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Basking Ridge (Consent and Followup), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction

Procedure

Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction

Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction

Procedure

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

quality-of-life questionnaires

Other

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

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.