Lymphedema Surveillance Study

Recruiting

• Conditions: Lymphedema; Breast Cancer
• Interventions: Other: Bilateral arm measurements; Other: Body mass index (BMI); Behavioral: Quality of Life Questionnaire; Other: Blood draw

• Registration Number: NCT02743858
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1250

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with SLNB alone	Body mass index (BMI)	Study requirements which include arm measurements, height and weight and completion of a questionnaire at a single long-term follow-up timepoint, will be explained to the patient
Patients who consent for ALND	Bilateral arm measurements	In patients treated with ALND, 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 \& the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements. Measurements will be performed at baseline (prior to surgery), post-operatively (after surgery) \& at scheduled timepoints of 6 months, 12 months, 18 months, \& 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, \& total surveillance time may exceed 2 years. Height \& weight will be obtained for each patient at baseline \& 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 \& at each scheduled visit.
Patients who consent for ALND	Quality of Life Questionnaire	In patients treated with ALND, 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 \& the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements. Measurements will be performed at baseline (prior to surgery), post-operatively (after surgery) \& at scheduled timepoints of 6 months, 12 months, 18 months, \& 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, \& total surveillance time may exceed 2 years. Height \& weight will be obtained for each patient at baseline \& 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 \& at each scheduled visit.
Patients treated with SLNB alone	Bilateral arm measurements	Study requirements which include arm measurements, height and weight and completion of a questionnaire at a single long-term follow-up timepoint, will be explained to the patient
ALND Translational Study Patients	Body mass index (BMI)	Patients will also be counseled about blood draws, which will include withdrawal of up to 20 mL of blood. Patients who are eligible and agree to participate will sign a consent form. Arm measurements, height and weight, blood draw (if applicable), and baseline questionnaire will be performed at first contact if possible, or at a follow-up scheduled visit prior to surgery.
Patients who consent for ALND	Body mass index (BMI)	In patients treated with ALND, 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 \& the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements. Measurements will be performed at baseline (prior to surgery), post-operatively (after surgery) \& at scheduled timepoints of 6 months, 12 months, 18 months, \& 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, \& total surveillance time may exceed 2 years. Height \& weight will be obtained for each patient at baseline \& 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 \& at each scheduled visit.
Patients treated with SLNB alone	Quality of Life Questionnaire	Study requirements which include arm measurements, height and weight and completion of a questionnaire at a single long-term follow-up timepoint, will be explained to the patient
ALND Translational Study Patients	Bilateral arm measurements	Patients will also be counseled about blood draws, which will include withdrawal of up to 20 mL of blood. Patients who are eligible and agree to participate will sign a consent form. Arm measurements, height and weight, blood draw (if applicable), and baseline questionnaire will be performed at first contact if possible, or at a follow-up scheduled visit prior to surgery.
ALND Translational Study Patients	Blood draw	Patients will also be counseled about blood draws, which will include withdrawal of up to 20 mL of blood. Patients who are eligible and agree to participate will sign a consent form. Arm measurements, height and weight, blood draw (if applicable), and baseline questionnaire will be performed at first contact if possible, or at a follow-up scheduled visit prior to surgery.
ALND Translational Study Patients	Quality of Life Questionnaire	Patients will also be counseled about blood draws, which will include withdrawal of up to 20 mL of blood. Patients who are eligible and agree to participate will sign a consent form. Arm measurements, height and weight, blood draw (if applicable), and baseline questionnaire will be performed at first contact if possible, or at a follow-up scheduled visit prior to surgery.

Primary Outcome Measures

Name	Time	Method
number of incidences of lymphedema	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.

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, 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 Westchester (Consent only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Basking Ridge (Consent only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Commack (Consent only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Nassau (Consent only); 🇺🇸 Uniondale, New York, United States