A Randomized Clinical Trial 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 a greater than or equal to 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 >6 nodes or radiation), radiation therapy (chest wall/ breast, supraclavicular fossa), or taxane-based chemotherapy. Following post-surgery 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 post-intervention progression to CDP, were assessed over three years. Between June 24, 2014 and September 11, 2018, 1,200 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 (IQR=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 was longer with BIS than TM (9.7; 95%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; RR=0.41; 95%CI,0.13-0.81; absolute reduction 11.3%; 95%CI,2.3%-20.3%; p = 0.016). Conclusions: As compared to TM, BIS provides a more precise identification of patients likely to benefit from an early compression intervention.

Temporal validation of a risk prediction model for breast cancer‐related lymphoedema in European population: A retrospective study

“…Furthermore, the results of a recent randomized controlled trial underline the importance of post‐surgical surveillance and early intervention (e.g. treatment with a compression sleeve and gauntlet) to limit lymphoedema progression in at‐risk patients (Ridner et al, 2021). In this respect, the prediction model tested here could form part of a prospective screening programme such as that described by Havens et al (2021), alerting the clinical team to a patient's at‐risk status and, therefore, the need to monitor arm volume so as to facilitate early detection of subclinical lymphoedema, while also educating the patient regarding appropriate self‐care.…”

Multidisciplinary preventive intervention for breast cancer‐related lymphedema: An international consensus

“…The other item that, surprisingly, fell just short of the consensus threshold in Round 1 (69.9% agreement) referred to the possibility of treatment as per the AMAROS trial (Donker et al, 2014) also noted that the timecourse for lymphedema development depended on the treatment received (e.g., the risk peaked between 18 and 24 months among women undergoing ALND + regional lymph node radiation), and hence monitoring would ideally continue for up to 3 years. Mention should also be made in this context of a recent randomised controlled trial showing that monitoring through BIS and early intervention can reduce the likelihood of progression to chronic BCRL (Ridner et al, 2021). Preoperative arm measurement can also play an important role, insofar as research suggests that these baseline measures may help to avoid underestimating or overestimating the risk of lymphedema (Sun et al, 2016).…”

“…In recent years, however, initiatives such as lymphedema education plans, the emergence of oncological physiotherapy as a recognised specialty in some countries, advances in surgical reconstruction of the lymphatic system and screening programmes have helped to reduce the incidence of BCRL. Furthermore, there is increasing evidence that prophylactic compression can be beneficial in delaying BCRL (Paramanandam et al, 2022;Ridner et al, 2021). Despite these developments, there is currently no crossdisciplinary consensus over how best to prevent BCRL, the result being health disparities among breast cancer patients.…”