Surveillance for Lymphedema
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how many women develop lymphedema (swelling due to fluid buildup) after undergoing axillary lymph node dissection during breast cancer surgery. Researchers will examine breast tissue to identify inflammation that might increase the risk of lymphedema. They will also ask participants about their quality of life to assess whether early detection can help. Women with breast cancer who are undergoing this type of surgery and meet certain criteria may be eligible to participate. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this surveillance method is safe for patients?
Previous studies have shown that measuring both arms is safe and effective for detecting changes in arm size after axillary lymph node dissection (ALND). These measurements help identify early signs of lymphedema, a condition where fluid builds up and causes swelling. Tools like the Perometer and tape measure have not been linked to any significant side effects.
Research also shows that tracking body mass index (BMI) is safe and important. While a higher BMI can increase the risk of developing lymphedema, measuring BMI itself poses no risk.
To assess quality of life, the Upper Limb Lymphedema 27 (ULL-27) questionnaire is used. This tool is reliable and safe, helping doctors understand how lymphedema affects daily life.
Overall, the methods used in this study, such as arm measurements, BMI monitoring, and quality-of-life questionnaires, are well-tolerated, with no major safety issues reported in previous research.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to enhance lymphedema management through comprehensive surveillance and monitoring. Unlike traditional treatments that primarily focus on post-diagnosis management, this approach emphasizes early detection through regular bilateral arm measurements and bioimpedance techniques, potentially allowing for timely interventions. The integration of quality-of-life assessments and the consideration of factors like BMI and COVID-19 vaccination status provide a holistic view of patient health, which could lead to more personalized and effective care strategies. By closely monitoring changes over time, this trial seeks to improve patient outcomes by catching lymphedema earlier and tailoring treatments to individual needs.
What evidence suggests that this trial's methods could be effective for detecting lymphedema?
In this trial, participants will undergo various surveillance methods to monitor for lymphedema. Research has shown that checking both arms for swelling can help detect lymphedema early. This swelling occurs when fluid accumulates. In the trial segment involving patients who consent to ALND, tools like the Perometer detect changes in arm size. Early detection and treatment can reduce the risk of long-term lymphedema. Studies indicate that a higher body mass index (BMI) can double the risk of developing lymphedema after surgery. Quality of life surveys, such as the LYMQOL, provide insights into how lymphedema affects daily living. These methods aim to enhance early detection and quality of life for those at risk.23467
Who Is on the Research Team?
Andrea Barrio, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline arm measurements, height, weight, and quality-of-life questionnaire are completed prior to surgery
Post-operative Monitoring
Participants undergo arm measurements and complete quality-of-life questionnaires at scheduled timepoints after surgery
Extended Surveillance
For participants diagnosed with lymphedema at ≥ 13 months, additional surveillance continues for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bilateral arm measurements
- Body mass index (BMI)
- Quality of Life Questionnaire
- Quality of Life Questionnaire and COVID-19 Vaccine Information
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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.
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 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Citations
LYMPHEDEMA SYMPTOMS AND LIMB MEASUREMENT ...
The 36-month cumulative incidence of lymphedema based on symptoms of arm heaviness was 26.0% (95% CI: 21.7, 31.1) and/or arm swelling was 30.9% (95% CI: 26.3, ...
NCT02743858 | Lymphedema Surveillance Study
In patients treated with ALND, bilateral arm measurements will be obtained using the Perometer (Model 350 NT Perometer, Per-System) circumferential arm ...
Measurement of breast cancer-related lymphoedema
This section summarises the most common clinically used methods of measurement for BCRL in the arm, touching on the protocols used for each measurement method.
Prospective Surveillance for Breast Cancer–Related Arm ...
The findings suggest that participation in prospective surveillance with early management reduces the risk of chronic BCRaL.
Decision-Making for Lymphedema Diagnostic and ...
TDC measurements suggested lymphedema at her left medial elbow, with percent water content (PWC) ratio 1.23 compared to the right elbow. ( ...
Surveillance Recommendations in Reducing Risk of and ...
A pre-operative history and physical, including bilateral arm volume measurements, allows for baseline information that is reliable as a prognostic ...
A Rational Approach to Lymphedema Risk Reduction ...
... bilateral arm volume measurements pre and postoperatively using a Perometer. The authors implied that a 10% increase in volume was synonymous with BCRL ...
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