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

Phase 3Active Not RecruitingNCT04241341

Memorial Sloan Kettering Cancer Center180 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Breast Cancer Lymphedema

Interventions

quality-of-life questionnairesOTHER

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 volumeOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (7)

Memorial Sloan Kettering Basking Ridge (Consent and Followup)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, United States

Outcomes

Primary Outcomes

the number of patients that had a decrease incidence of lymphedema

as measured by arm volume will be a ≥10% increase in arm volume

Time frame: up to 2 years