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Podcast Chirag Shah, MD @CShahMD @ClevelandClinic #BCRL PREVENT Study on BCRL Prevention

Chirag Shah, MD, Director of Breast Radiation Oncology and Director of Clinical Research in the Department of Radiation Oncology at Cleveland Clinic. In this video, he speaks about the abstract – A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention.

 

Overview –

Origins:

Following a subclinical lymphedema (S-BCRL) intervention triggered by bioimpedance spectroscopy (BIS) or tape measurement, rates of progression to chronic breast cancer-related lymphedema (defined as a 10% arm volume change from baseline requiring complex decongestive physiotherapy [CDP]) were compared (TM).

Findings and Methodologies:

New breast cancer patients undergoing mastectomy/partial mastectomy, axillary treatment (dissection, sentinel lymph node biopsy [SLNB] >6 nodes or radiation), radiation therapy (chest wall/breast, supraclavicular fossa), or taxane-based chemotherapy were enrolled in this stratified, randomized, international trial. Following a centralized, 1:1 randomization to prospective surveillance by BIS or TM, patients were randomized to prospective surveillance by BIS or TM. When S-BCRL was detected, a 4-week, 12-hour-per-day compression sleeve and gauntlet intervention was initiated. Over a three-year period, the primary outcome (n = 209) was assessed: rates of postintervention progression to CDP. 1200 individuals were enrolled between June 24, 2014 and September 11, 2018, with 963 being randomized (BIS n = 482; TM n = 481) and 879 being analyzed (BIS n = 442; TM n = 437). The median time between visits was 32.9 months (interquartile range = 22, 35). BIS patients were less likely than TM patients to require intervention (20.1 percent, n = 89 vs. 27.5 percent, n = 120, p = 0.011). BIS took longer to trigger than TM (9.7; 95 percent confidence interval [CI], 8.2–12.6 vs. 3.9; 95 percent confidence interval [CI], 2.8–4.5, p = 0.001). Overall, 14.4% (n = 30) of BIS patients advanced after treatment, with a lower chance for TM patients (7.9%, n = 7 vs. 19.2%, n = 23; relative risk = 0.41; 95 percent CI, 0.13–0.81; absolute reduction 11.3 percent; 95 percent CI, 2.3–20.3; p = 0.016).

Observations:

In comparison to TM, BIS allows for a more exact diagnosis of patients who would benefit from early compression therapy.

NCT02167659 is the number assigned to a clinical trial.

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