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Open Access 01-12-2023 | Lymphedema | Study protocol

Complex physical therapy employing self-adjusting garment (ReadyWrap®) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trial

Authors: Jéssica Malena Pedro da Silva, Raul Denner Duarte Araújo, Francisca Cristina da Silva Santos, Erica Alves Nogueira Fabro, Marcus Vinicius de Mello Pinto, Suzana Sales de Aguiar, Luiz Claudio Santos Thuler, Anke Bergmann

Published in: Trials | Issue 1/2023

Abstract

Background

Lymphedema is a common complication following breast cancer treatment. The aim of this study is to evaluate the effectiveness of a self-adjusting compression garment (ReadyWrap®) in reducing (phase 1) and maintaining (phase 2) upper limb volume in women presenting breast cancer-related lymphedema.

Methods

This study will comprise a randomized, controlled, single-blind clinical trial concerning women with breast cancer-related lymphedema undergoing treatment at a public cancer treatment reference hospital in the city of Rio de Janeiro, Brazil. The intervention will be carried out by adapting self-dressing versus the standard treatment of compressive bandaging (phase 1) and compressive mesh (phase 2). Both groups will be assessed at the beginning and end of intensive treatment and followed up for up to 12 months to evaluate immediate and late outcomes. Assessments will be carried out by physical upper limb examination (inspection, palpation, volume, dynamometry, and thermography) and questionnaires application to assess patient’s quality of life pertaining to the health, functionality, and symptoms of the affected upper limb, as well adverse effects and adherence to treatment. Data will be analyzed descriptively and analytically through univariate and multiple linear regressions. P values < 0.05 will be considered statistically significant.

Discussion

This study will evaluate the effectiveness of a self-adjustable garment (ReadyWrap®) in the treatment of lymphedema secondary to breast cancer in Brazilian women compared to the gold standard treatment for limb volume reduction (phase 1) and maintenance (phase 2) phases comprising, respectively, a compressive bandaging and a compressive mesh. The outcome results will provide data based on both quantitative responses and self-reported participant outcomes. The study will also assess the cost-effectiveness of the ReadyWrap® treatment versus standard care. Finally, we expect to reaffirm one more product/therapy as a treatment for this extremely complex and impactful condition following the data analysis.

Trial registration

NCT04934098 [Clinical trials phase 1]. Registered on June 22, 2021. NCT04881604 [Clinical trials phase 2]. Registered on May 11, 2021.

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Title: Complex physical therapy employing self-adjusting garment (ReadyWrap®) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trial
Authors: Jéssica Malena Pedro da Silva
Raul Denner Duarte Araújo
Francisca Cristina da Silva Santos
Erica Alves Nogueira Fabro
Marcus Vinicius de Mello Pinto
Suzana Sales de Aguiar
Luiz Claudio Santos Thuler
Anke Bergmann
Publication date: 01-12-2023
Publisher: BioMed Central
Keywords: Lymphedema
Breast Cancer
Breast Cancer
Published in: Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-023-07460-4

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Complex physical therapy employing self-adjusting garment (ReadyWrap®) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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