Efficacy, safety of and adherence to adjustable compression wraps in the control phase of breast cancer-related lymphedema: A randomized controlled trial

Author:

Silva Jéssica Malena Pedro da1ORCID,Araújo Raul Denner Duarte1,Aguiar Suzana Sales de1,Fabro Erica Alves Nogueira2,Pinto Marcus Vinicius de Mello3,Thuler Luiz Claudio Santos1,Bergmann Anke1ORCID

Affiliation:

1. Division of Clinical Research and Technological Development, Brazilian National Cancer Institute (INCA), Rio de Janeiro, RJ, Brazil

2. Hospital Cancer III, Brazilian National Cancer Institute (INCA), Rio de Janeiro, RJ, Brazil

3. Institute Celulare, Rio de Janeiro, RJ, Brazil

Abstract

Objective To evaluate efficacy, safety, and adherence to using adjustable compression wraps (ACWs) for upper limb volume control in women with breast cancer-related lymphedema. Design and Setting Randomized controlled trial at a reference hospital for breast cancer treatment in Brazil. Participants Women in control phase of the breast cancer-related lymphedema. Interventions Compared use of ACWs versus compressive mesh. Main Measures Evaluated before treatment, at 30 days, and 6 months after initiating therapy. The primary outcome was the change in excess limb volume. Secondary outcomes included adherence, incidence of adverse events, functionality, quality of life, and hand grip. Statistical analysis involved calculating the effect size (ES) with a 95% confidence interval. Results Were included 71 women with mean excess limb volume of 321.79 mL (±194.98). In the 30-day analysis (Time 1), a reduction of 37.6 mL in volume was observed only in the ACW group ( p = .041, ES 0.20), with improved functionality ( p = .013, ES 0.22). In the six months analysis (Time 2), the compressive mesh group increased by 2.48% in volume ( p = .023, ES 0.26) and demonstrated improvement functionality ( p = .036, ES 0.27). Mild adverse events and satisfactory adherence were observed. However, in the intergroup comparison, no statistically significant difference was observed for any evaluated outcome—excess volume, incidence of adverse events, adherence, hand grip, quality of life, and functionality between the groups ( p > .05) at both times. Conclusions Both compression therapies achieved satisfactory adherence, were safe, effective and equivalent for controlling limb volume in breast cancer-related lymphedema.

Funder

VENOSAN BRASIL LTDA

Instituto Nacional do Câncer, Ministério da Saúde

Publisher

SAGE Publications

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