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Lymphedema Surveillance Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how many women get lymphedema (swelling from fluid buildup) after surgery to remove underarm lymph nodes for breast cancer. Researchers will test removed breast tissue for inflammation that may raise the risk of swelling. They will also ask how swelling affects daily life and study whether finding it earlier helps women.

This study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. The investigators also want to look for reasons why some women get lymphedema and others don't. Specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a woman's risk for lymphedema. The investigators will also ask the patient to answer questions to see how much their quality of life is affected by lymphedema, and whether this study can help women by detecting lymphedema earlier.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women with breast cancer who are older than 18.
  • Agreeing to surgery to remove lymph nodes from one underarm (ALND). A past sentinel lymph node biopsy is allowed if it was less than 6 months before joining.
  • Women planning a sentinel lymph node biopsy (removal of the first nodes checked for cancer) and possible ALND may join at first, but cannot continue if ALND is not done.
  • Women who first joined but could not continue because they had only a sentinel lymph node biopsy will be asked to join again.
  • Women who identify as Black or White and plan ALND or possible ALND on one side will be asked to join the tissue-testing part of the study (Group 3).

Who can't join

  • Men with breast cancer.
  • Planning surgery on lymph nodes in both underarms.
  • Had one or more underarm lymph nodes removed, including a sentinel lymph node biopsy, more than 6 months before agreeing to join.
  • Have had ALND before.
  • Have not had breast surgery at MSK.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (7)

NJ

NY