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

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.