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

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 sympto ms 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.DiscussionThis 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 dat a based on both quantitative response...
Source: Trials - Category: Research Source Type: clinical trials