A randomized trial evaluating bioimpedance spectroscopy versus tape measurement for the prevention of lymphedema following treatment for breast cancer: interim analysis

Sheila H. Ridner, Mary S. Dietrich, Michael S. Cowher, Bret Taback, Sarah McLaughlin, Nicolas Ajkay, John Boyages, Louise Koelmeyer, Sarah DeSnyder, Jamie Wagner, Vandana Abramson, Andrew Moore, Chirag Shah

Research output: Contribution to journalArticleResearchpeer-review

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.
LanguageEnglish
Pages3250-3259
Number of pages9
JournalAnnals of Surgical Oncology
Volume26
Issue number10
DOIs
Publication statusPublished - Oct 2019

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Lymphedema
Spectrum Analysis
Breast Neoplasms
Therapeutics
Survivors
Randomized Controlled Trials
Morbidity
Breast Cancer Lymphedema

Bibliographical note

Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Cite this

Ridner, Sheila H. ; Dietrich, Mary S. ; Cowher, Michael S. ; Taback, Bret ; McLaughlin, Sarah ; Ajkay, Nicolas ; Boyages, John ; Koelmeyer, Louise ; DeSnyder, Sarah ; Wagner, Jamie ; Abramson, Vandana ; Moore, Andrew ; Shah, Chirag. / A randomized trial evaluating bioimpedance spectroscopy versus tape measurement for the prevention of lymphedema following treatment for breast cancer : interim analysis. In: Annals of Surgical Oncology. 2019 ; Vol. 26, No. 10. pp. 3250-3259.
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title = "A randomized trial evaluating bioimpedance spectroscopy versus tape measurement for the prevention of lymphedema following treatment for breast cancer: interim analysis",
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.",
author = "Ridner, {Sheila H.} and Dietrich, {Mary S.} and Cowher, {Michael S.} and Bret Taback and Sarah McLaughlin and Nicolas Ajkay and John Boyages and Louise Koelmeyer and Sarah DeSnyder and Jamie Wagner and Vandana Abramson and Andrew Moore and Chirag Shah",
note = "Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.",
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A randomized trial evaluating bioimpedance spectroscopy versus tape measurement for the prevention of lymphedema following treatment for breast cancer : interim analysis. / Ridner, Sheila H.; Dietrich, Mary S.; Cowher, Michael S.; Taback, Bret; McLaughlin, Sarah; Ajkay, Nicolas; Boyages, John; Koelmeyer, Louise; DeSnyder, Sarah; Wagner, Jamie; Abramson, Vandana; Moore, Andrew; Shah, Chirag.

In: Annals of Surgical Oncology, Vol. 26, No. 10, 10.2019, p. 3250-3259.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - A randomized trial evaluating bioimpedance spectroscopy versus tape measurement for the prevention of lymphedema following treatment for breast cancer

T2 - Annals of Surgical Oncology

AU - Ridner,Sheila H.

AU - Dietrich,Mary S.

AU - Cowher,Michael S.

AU - Taback,Bret

AU - McLaughlin,Sarah

AU - Ajkay,Nicolas

AU - Boyages,John

AU - Koelmeyer,Louise

AU - DeSnyder,Sarah

AU - Wagner,Jamie

AU - Abramson,Vandana

AU - Moore,Andrew

AU - Shah,Chirag

N1 - Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2019/10

Y1 - 2019/10

N2 - 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.

AB - 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.

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U2 - 10.1245/s10434-019-07344-5

DO - 10.1245/s10434-019-07344-5

M3 - Article

VL - 26

SP - 3250

EP - 3259

JO - Annals of Surgical Oncology

JF - Annals of Surgical Oncology

SN - 1068-9265

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ER -