A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention

Abstract

Background: This study compared rates of progression to chronic breast cancer-related lymphedema (defined as ≥ 10% arm volume change from baseline requiring complex decongestive physiotherapy [CDP]) following an intervention for subclinical lymphedema (S-BCRL) triggered by bioimpedance spectroscopy (BIS) or by tape measurement (TM). Methods and Results: This stratified, randomized, international trial enrolled 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. Following postsurgery eligibility reassessment, centralized, 1:1 randomization to prospective surveillance by BIS or TM occurred. S-BCRL detection triggered a 4-week, 12-hour per day, compression sleeve, and gauntlet intervention. The primary outcome ( n = 209), rates of postintervention progression to CDP, was assessed over 3 years. Between June 24, 2014 and September 11, 2018, 1200 patients were enrolled, 963 randomized (BIS n = 482; TM n = 481) and 879 analyzed (BIS n = 442; TM n = 437). Median follow-up was 32.9 months (interquartile range = 22, 35). BIS patients triggered an intervention at a lower rate than TM patients (20.1%, n = 89 vs. 27.5%, n = 120, p = 0.011). Median months to trigger were longer with BIS than TM (9.7; 95% confidence interval [CI], 8.2–12.6 vs. 3.9; 95% CI, 2.8–4.5, p = 0.001). Overall, 14.4% ( n = 30) progressed post-intervention, with reduced likelihood for BIS patients than TM patients (7.9%, n = 7 vs. 19.2%, n = 23; relative risk = 0.41; 95% CI, 0.13–0.81; absolute reduction 11.3%; 95% CI, 2.3–20.3; p = 0.016). Conclusions: Compared to TM, BIS provides a more precise identification of patients likely to benefit from an early compression intervention. Clinical Trial Registration number: NCT02167659.

Risk factors for breast cancer–related lymphedema in patients undergoing 3 years of prospective surveillance with intervention

“…Risk reduction education should be targeted according to the current evidence and level of risk and encourage active patient participation in PSEI for the duration of the monitoring period. Finally, patients in this study were seen in high‐volume cancer clinics by trained research staff who performed the measures and initiated an intervention 6‐9 . This demonstrates that the PSEI model is not dependent on trained lymphedema therapists for successful outcomes and that referrals to certified lymphedema therapists when patients progress after subclinical intervention may be best practice.…”

“…1). 7 Of those, 45 had no postrandomization assessments; thus, a sample of 918 (457 TM, 461 BIS) patients was included in the outcome analyses. Almost one‐half of all the patients (42.4%) had some type of chemotherapy and, if they did, 88.4% had taxane‐based chemotherapy.…”

“…Baseline physical measurements and self‐report data were collected presurgery. Patients were randomized postoperatively to surveillance with either BIS or TM, with procedures previously documented 7‐9,38,39 . Both assessment methods have been previously validated by the principal investigator of the parent study along with other published validation studies 40‐44 .…”

“…A prospective, multisite, international randomized, controlled trial enrolled women with newly diagnosed breast cancer before surgery, eligibility, and exclusion criteria previously published. [7][8][9] Study approval from all local research review boards, protocol posting on www.Clini calTr ials.gov, and informed consent were all obtained before enrollment in the study.…”

“…[2][3][4] The PSEI model integrates routine measurement, risk assessment, risk-reduction education, and, ideally, compression therapy intervention for subclinical BCRL, all of which are key to reducing chronic BCRL risk. 5,6 Identification of change only in extracellular fluid using bioimpedance spectroscopy (BIS)-driven interventions for subclinical BCRL have been associated with less progression to chronic BCRL [7][8][9] than has identification of whole arm volume change (e.g., tape measurement [TM]) [7][8][9] when following the PSEI model, which includes a short compression intervention.…”