Lymphedema Surveillance Study

Overview

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.

Full Title of Study: “A Prospective Surveillance Program for Assessment and Treatment of Breast Cancer-Related Lymphedema After Axillary Lymph Node Dissection”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2021

Interventions

  • Other: Bilateral arm measurements
    • will be obtained using the Perometer (Model 350 NT Perometer, Per-System) circumferential arm measurements with elastic tape taken at 4-cm intervals from the wrist to the shoulder, and the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements.
  • Other: Body mass index (BMI)
    • Height and weight will be obtained for each patient at baseline and at each scheduled visit for the purpose of calculating BMI. BMI will be correlated with the presence of inflammatory biomarkers in the tissue, as well as with lymphedema development.
  • Behavioral: Quality of Life Questionnaire

Arms, Groups and Cohorts

  • Breast Cancer-Related Lymphedema
    • Bilateral arm measurements will be obtained using the Perometer (Model 350 NT Perometer, Per-System) circumferential arm measurements with elastic tape taken at 4-cm intervals from the wrist to the shoulder and the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements. Measurements will be performed at baseline (prior to surgery), post-operatively (after surgery) and at scheduled timepoints of 6 months, 12 months, 18 months, and 24 months after surgery for a total of 2 years. For a patient who is diagnosed with lymphedema at ≥ 13 months after surgery, surveillance will continue for an additional 12 months after [lymphedema] diagnosis, and total surveillance time may exceed 2 years. Height and weight will be obtained for each patient at baseline and at each scheduled visit for the purpose of calculating BMI. All patients will complete the ULL-27 (upper limb lymphedema) quality-of-life questionnaire at baseline and at each scheduled visit.

Clinical Trial Outcome Measures

Primary Measures

  • number of incidences of lymphedema
    • Time Frame: 2 year
    • as defined by perometry using rigorous measurement protocols. Bilateral arm measurements will be obtained using the Perometer (Model 350 NT Perometer, Per-System) and the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements.

Participating in This Clinical Trial

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

Exclusion Criteria

  • Male breast cancer patients
  • Patients treated with SLNB only
  • 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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrea Barrio, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
  • Overall Contact(s)
    • Andrea Barrio, MD, 646-888-5117

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