Screening Devices for Breast Cancer Lymphedema

Overseen By Alphonse G. Taghian, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Targeted therapy

Disqualifiers: Limited shoulder mobility

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Variable, based on individual treatment plans

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to monitor swelling and the onset of lymphedema (a type of swelling) in breast cancer patients receiving targeted therapy treatments. Researchers will use devices called Perometer and SOZO to track changes in limb volume over time. The trial seeks women who have had breast cancer, are at least four weeks post-surgery, and are undergoing targeted therapy for early or advanced (metastatic) stages of the disease. Women fitting this profile and interested in understanding how targeted therapy might affect the risk of developing lymphedema may find this trial suitable. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could improve future treatment strategies for breast cancer patients.

Do I need to stop my current medications for this 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 the Perometer and SOZO device are safe for measuring volume changes in breast cancer patients?

Research has shown that the SOZO device, which monitors body fluid and tissue changes, is FDA-approved for assessing lymphedema. This approval indicates it has been tested for safety in evaluating lymphedema, a condition characterized by swelling due to fluid build-up. The Perometer, another device used in these studies, is frequently employed in clinics to accurately measure limb swelling. Both devices are non-invasive, meaning they do not cause pain or harm.

No major safety concerns have been reported with using these devices for monitoring lymphedema. They assist in tracking changes in limb size, enabling doctors to detect early signs of lymphedema in patients receiving targeted breast cancer treatment. While the devices are safe, discussing any concerns or questions with a healthcare provider remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to screen for lymphedema in breast cancer patients using the Perometer and SOZO devices. Unlike traditional screening methods, these devices offer precise limb volume measurements, which can help detect lymphedema earlier. Early detection is crucial because it enables timely intervention, potentially preventing the progression of this condition. By incorporating these devices into regular follow-up visits, the trial aims to improve patient outcomes and enhance the quality of care for those undergoing targeted therapy for breast cancer.

What evidence suggests that the Perometer and SOZO device are effective for tracking edema and BCRL onset in breast cancer patients?

Research has shown that both the Perometer and SOZO device reliably measure limb volume, crucial for monitoring lymphedema, a condition where fluid accumulates in tissues, causing swelling. Studies have found that the Perometer accurately measures arm volume. The SOZO device uses bioimpedance, a method that assesses how body tissues resist tiny electrical currents, to detect changes in fluid levels and track lymphedema over time. In this trial, participants will have their limb volume measured with these devices during follow-up visits. These devices provide consistent and precise data, aiding in the early detection and management of Breast Cancer Related Lymphedema (BCRL). This can guide treatment decisions and improve outcomes for patients receiving targeted therapy for breast cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Alphonse G. Taghian, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF/HCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.

With a history of breast cancer

4 weeks or more post-surgery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive targeted therapy treatments for early and metastatic breast cancer

Variable, based on individual treatment plans

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with limb volume measurements using Perometer and SOZO

6 months

Follow-up visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Perometer
• SOZO device

How Is the Trial Designed?

Group I: Target Therapy-Early or Metastatic Breast Cancer Experimental Treatment 2 Interventions

Screening procedures confirm participation in the research study. * Participants limb volume is measured prior to treatment start date. * Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card. * Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication

Group II: Target Therapy Drug-Stand Care Experimental Treatment 2 Interventions

Screening procedures confirm participation in the research study. * Participants limb volume is measured prior to treatment start date. * Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card. * Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Heinz Family Foundation

Collaborator

Trials

3

Recruited

310+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10985575/

Comparison of Volume Measurements and Bioimpedance ... This study aimed to evaluate the performance of a stand-on BIS device for detection of BCRL, introduce a novel graphical method to compare volumetric and BIS ...

2. researchgate.net researchgate.net/publication/320090714_Measuring_Limb_Volume_Accuracy_and_Reliability_of_Tape_Measurement_Versus_Perometer_Measurement

(PDF) Measuring Limb Volume: Accuracy and Reliability of ... PDF | Background: Accurate limb volume measurement is key in the assessment of outcomes in lymphedema microsurgery.

3. impedimed.com impedimed.com/wp-content/uploads/2020/09/LBL-537-EN-Rev-F-SOZO-App-and-System-Instructions-For-Use-OUS.pdf

SOZO System Instructions for Use The Clinician uses the SOZO Device to: take and record measurements of patients; view and evaluate measurements and. Assessments over time; and assess patient ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06606145

Study Details | NCT06606145 | Reduction of Arm Volume ... Limb volume will be assessed using a perometer, an objective and reliable tool for measuring arm volume. Secondary outcomes include improvement ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7882272/

Use of technology to facilitate a prospective surveillance ... Our prospective screening program consists of longitudinal measurements via perometry, symptoms assessment, and clinical examination by a certified lymphedema ...

6. impedimed.com impedimed.com/products/sozo/

SOZO® Digital Health Platform The SOZO Digital Health Platform is the only FDA-cleared bioimpedance spectroscopy (BIS) solution for the clinical assessment of lymphedema.

7. sciencedirect.com sciencedirect.com/science/article/pii/S183695532200087X

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.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7343436/

Breast Cancer–Related Lymphedema: Risk Factors, ... These data, together with a recent meta-analysis, validate the AMAROS trial data, suggesting the significant reduction of BCRL rates if RLNR replaces ALND in ...

9. massgeneral.org massgeneral.org/cancer-center/treatments-and-services/breast-cancer/lymphedema

Breast Cancer-Related Lymphedema Program We take this measurement using a device called a perometer. Perometers use ... Further measurements are then taken during and after your breast cancer treatment.

10. capbluecross.com capbluecross.com/wps/wcm/connect/prod_nws.capblue.com29556/18359686-d2e0-46f8-a456-94cada325117/medical-policy-bioimpedance-devices-for-detection-and-management-of-lymphedema.pdf?MOD=AJPERES&CACHEID=ROOTWORKSPACE.Z18_4G00HA41L8PI50ALUD09N53000-18359686-d2e0-46f8-a456-94cada325117-ovYCHYE

medical-policy-bioimpedance-devices-for-detection-and- ... Devices using bioimpedance (bioelectrical impedance spectroscopy) may be considered medically necessary for individuals at risk of developing lymphedema (e.g., ...