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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 3

Conditions: Breast Cancer Lymphedema

Treatments: Other: measured by arm volume; Other: quality-of-life questionnaires; Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction; Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT04241341

20-021

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

axillary lymph node dissection with ILR

Experimental group

Treatment:

Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction

Other: quality-of-life questionnaires

Other: measured by arm volume

axillary lymph node dissection (ALND) without ILR

Active Comparator group

Treatment:

Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction

Other: quality-of-life questionnaires

Other: measured by arm volume