dc.contributor.author | Ridner, Sheila H. | |
dc.contributor.author | Dietrich, Mary S. | |
dc.contributor.author | Cowher, Michael S. | |
dc.contributor.author | Taback, Bret | |
dc.contributor.author | McLaughlin, Sarah | |
dc.contributor.author | Ajkay, Nicolas | |
dc.contributor.author | Boyages, John | |
dc.contributor.author | Koelmeyer, Louise | |
dc.contributor.author | DeSnyder, Sarah M. | |
dc.contributor.author | Wagner, Jamie | |
dc.contributor.author | Abramson, Vandana | |
dc.contributor.author | Moore, Andrew | |
dc.contributor.author | Shah, Chirag | |
dc.date.accessioned | 2020-08-19T23:15:26Z | |
dc.date.available | 2020-08-19T23:15:26Z | |
dc.date.issued | 2019-10 | |
dc.identifier.citation | Ridner, S. H., Dietrich, M. S., Cowher, M. S., Taback, B., McLaughlin, S., Ajkay, N., Boyages, J., Koelmeyer, L., DeSnyder, S. M., Wagner, J., Abramson, V., Moore, A., & Shah, C. (2019). A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer: Interim Analysis. Annals of surgical oncology, 26(10), 3250–3259. https://doi.org/10.1245/s10434-019-07344-5 | en_US |
dc.identifier.issn | 1068-9265 | |
dc.identifier.uri | http://hdl.handle.net/1803/10382 | |
dc.description.abstract | Background Breast cancer-related lymphedema (BCRL) represents a major source of morbidity among breast cancer survivors. Increasing data support early detection of subclinical BCRL followed by early intervention. A randomized controlled trial is being conducted comparing lymphedema progression rates using volume measurements calculated from the circumference using a tape measure (TM) or bioimpedance spectroscopy (BIS). Methods Patients were enrolled and randomized to either TM or BIS surveillance. Patients requiring early intervention were prescribed a compression sleeve and gauntlet for 4 weeks and then re-evaluated. The primary endpoint of the trial was the rate of progression to clinical lymphedema requiring complex decongestive physiotherapy (CDP), with progression defined as a TM volume change in the at-risk arm >= 10% above the presurgical baseline. This prespecified interim analysis was performed when at least 500 trial participants had >= 12 months of follow-up. Results A total of 508 patients were included in this analysis, with 109 (21.9%) patients triggering prethreshold interventions. Compared with TM, BIS had a lower rate of trigger (15.8% vs. 28.5%, p < 0.001) and longer times to trigger (9.5 vs. 2.8 months, p = 0.002). Twelve triggering patients progressed to CDP (10 in the TM group [14.7%] and 2 in the BIS group [4.9%]), representing a 67% relative reduction and a 9.8% absolute reduction (p = 0.130). Conclusions Interim results demonstrated that post-treatment surveillance with BIS reduced the absolute rates of progression of BCRL requiring CDP by approximately 10%, a clinically meaningful improvement. These results support the concept of post-treatment surveillance with BIS to detect subclinical BCRL and initiate early intervention. | en_US |
dc.description.sponsorship | This study was funded by ImpediMed, Inc. and in-kind garment donations provided by medi. Study data were collected and managed using REDCap electronic data capture tools hosted at Vanderbilt University. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources.<SUP>22</SUP> | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | Annals of Surgical Oncology | en_US |
dc.rights | Copyright © The Author(s) 2019
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. | |
dc.source.uri | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6733825/ | |
dc.title | A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer-Interim Analysis | en_US |
dc.type | Article | en_US |
dc.identifier.doi | 10.1245/s10434-019-07344-5 | |