Pretreatment Baseline Screening for Breast Cancer-Related Lymphedema

New results from a breast cancer-related lymphedema study show the importance of measuring fluid and body composition before treatment begins: © H_Ko - stock.adobe.com.

Baseline assessments conducted before breast cancer treatment increased the chance of identifying breast cancer-related lymphedema at an earlier stage after treatment, according to data from the PREVENT trial, which were shared in a news release from ImpediMed.

Without a pretreatment baseline, up to 71% of patients monitored with bioimpedance spectroscopy and up to 88% of those monitored with tape measure would not have been identified as having early signs of lymphedema, potentially missing the opportunity for earlier, more effective treatment, according to findings from PREVENT. Notably, this trial is the largest randomized controlled trial to evaluate lymphedema prevention, the news release emphasized.

PREVENT evaluates 1,200 patients and tracks progression to chronic breast cancer-related lymphedema following early intervention, as assessed by both bioimpedance spectroscopy and traditional tape measurement.

"This evidence reinforces the critical importance of establishing an easy-to-perform, baseline measurement for fluid and body composition, one that improves the likelihood of detecting [breast cancer-related lymphedema] as early as possible so lymphedema treatment can begin at its most reversible stages," Dr. Steven L. Chen, the study’s lead author and ImpediMed's chief medical officer, said in the news release. "These findings highlight the importance of paying attention to lymphedema risk even as the cancer treatment is being planned."

ImpediMed offers the only U.S. Food and Drug Administration (FDA)-cleared bioimpedance spectroscopy solution for the clinical assessment of lymphedema — SOZO Digital Health Program. The platform is now recommended nationwide in clinical practice guidelines and is generally accepted and recognized for accurate and effective screening of lymphedema.

SOZO, a noninvasive bioimpedance spectroscopy device, provides a fluid and tissue snapshot in under 30 seconds using 256 data points across multiple frequencies. Cleared by the FDA and designed for use across health systems, SOZO helps detect secondary lymphedema, track fluid status in patients with heart or kidney failure and support overall health monitoring.

Furthermore, the National Comprehensive Cancer Network updated its Breast Cancer Clinical Practice Guidelines recently, which advises on baseline pretreatment screening for patients with lymphedema risk factors. This reinforces the importance of measuring at baseline to support early detection of lymphedema.

"I'm proud to support research that highlights the benefits of closer monitoring for breast cancer survivors," Scott Long, newly appointed senior vice president of sales at ImpediMed, said in the news release. "It's rewarding to see survivorship care gaining momentum — something I've championed throughout my 30-year career in breast cancer biopsy and device development."

More on the PREVENT Trial

The PREVENT trial enrolled patients across 10 sites in the U.S. and Australia, including 13 hospitals such as Vanderbilt University, Mayo Clinic and The University of Texas MD Anderson Cancer Center. Conducted over six and a half years, the study followed patients for up to three years to evaluate whether early intervention after subclinical detection of extracellular fluid buildup via bioimpedance spectroscopy could reduce lymphedema progression compared with detection with a tape measure. The findings were published in Lymphatic Research and Biology.

Results showed a 7.9% rate of chronic lymphedema in patients monitored with L-Dex technology and treated early with compression garments compared with 19.2% in those assessed with tape measure. The 11.3% difference was statistically significant and represented a 59% relative reduction in progression at three years, offering meaningful clinical benefit for patients and clinicians, as per the release.

Additional insights based on these findings will be presented during a poster session at the 2025 American Society of Breast Surgeons Annual Meeting in Las Vegas, Nevada, on Friday, May 2, at 6:00 p.m. The study is titled, "The Importance of a Pre-Treatment Baseline When Screening Patients for Breast Cancer–Related Lymphedema." The study will be presented by Chen.

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