Monitoring lymphedema in women after breast cancer surgery

A Prospective Surveillance Program for Assessment and Treatment of Breast Cancer-Related Lymphedema After Axillary Lymph Node Dissection

This study looks at how often women develop lymphedema after breast cancer surgery and how it affects their daily lives, to help catch it early and improve their care.

Quick facts

• Study type: Observational
• Enrollment: 1250 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Memorial Sloan Kettering Cancer Center (other)
• Locations: 7 sites (Basking Ridge, New Jersey and 6 other locations)
• Trial ID: NCT02743858 on ClinicalTrials.gov

What this trial studies

This observational study aims to determine the incidence of lymphedema in women following axillary lymph node dissection for breast cancer. Investigators will analyze breast tissue samples to identify inflammation that may contribute to the development of lymphedema. Participants will also complete quality of life questionnaires to assess the impact of lymphedema on their daily lives. The study seeks to enhance early detection of lymphedema, potentially improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are female breast cancer patients over the age of 18 who are undergoing unilateral axillary lymph node dissection.

Not a fit: Patients who are male or those undergoing bilateral axillary surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and better management of lymphedema in breast cancer patients.

How similar studies have performed: Other studies have shown success in monitoring lymphedema, making this approach a continuation of established research.

Eligibility criteria

Inclusion Criteria:

* Female breast cancer patients over the age of 18
* Patients consenting for unilateral axillary lymph node dissection (ALND) (prior history of sentinel lymph node biopsy allowed if \<6 months from consent)
* Patients consenting for unilateral sentinel lymph node biopsy (SLNB) and possible ALND are eligible for initial entry into the study, but will become ineligible if ALND is not performed
* Initially consented patients, treated with SLNB alone, who were originally considered ineligible to continue on study, will be approached for re-enrollment
* Patients who self-identify as Black or White consenting for unilateral ALND or possible ALND will be approached for enrollment onto translational study (Cohort 3)

Exclusion Criteria:

* Male breast cancer patients
* Patients consenting for bilateral axillary surgery
* Patients with prior history of surgical excision of one or more axillary lymph nodes or SLNB, performed \>6 months from date of consent
* Patients with prior history of ALND
* Patients with no breast surgery performed at MSK

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

• Memorial Sloan Kettering Basking Ridge (Consent only) — Basking Ridge, New Jersey, United States (RECRUITING)
• Memorial Sloan Kettering Monmouth (Consent only) — Middletown, New Jersey, United States (RECRUITING)
• Memorial Sloan Kettering Bergen (Consent only) — Montvale, New Jersey, United States (RECRUITING)
• Memorial Sloan Kettering Commack (Consent only) — Commack, New York, United States (RECRUITING)
• Memorial Sloan Kettering Westchester (Consent only) — Harrison, New York, United States (RECRUITING)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
• Memorial Sloan Kettering Nassau (Consent only) — Uniondale, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Andrea Barrio, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Andrea Barrio, MD

Conditions: Breast Cancer, Lymphedema, Surveillance Program, Axillary Lymph Node Dissection, 16-220