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:

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.

• 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
• Journal: Trials (Trials) Vol. 24 Issue 1 Pg. 549 (Aug 22 2023) ISSN: 1745-6215 [Electronic] England
• PMID: 37608354 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: © 2023. BioMed Central Ltd., part of Springer Nature.

Topics

• Humans
• Female
• Brazil
• Breast Neoplasms (complications)
• Quality of Life
• Single-Blind Method
• Physical Therapy Modalities
• Breast Cancer Lymphedema (diagnosis, etiology, therapy)
• Lymphedema (diagnosis, etiology, therapy)
• Randomized Controlled Trials as Topic