NCT04934098

Adjustable Compression Wrap Versus Compression Bandage Reduce to Breast Cancer-related Lymphedema

Compressive Therapy by Adjustable Compression Garment (Ready Wrap®) in Breast Cancer-related Lymphedema: Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Instituto Nacional de Cancer, Brazil · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized clinical trial with women with lymphedema secondary to breast cancer. The intervention will consist of the use of self-adjusting clothing versus compressive bandaging (routine treatment of the institution). Self-adjusting clothing is expected to be more effective for the treatment of lymphedema reduction, when compared to standard treatment, in addition to promoting a better quality of life and functionality.

Detailed description

This is a randomized clinical trial, simple blind, which aims to evaluate the effectiveness of the use of self-adjusting compression garments (Read Wrap®) in reducing the volume of the upper limb of women with lymphedema secondary to breast cancer. It will be carried out in a referral hospital for the treatment of breast cancer in Brazil, with inclusion scheduled for June 2021 and follow-up of up to 1 year. All volunteers must have lymphedema in the upper limb after surgical treatment for breast cancer for more than 6 months, indicating phase 1 of compressive therapy. According to the sample calculation, 72 women will be needed to be randomly randomized in a 1: 1 ratio among the experimental intervention group (n = 36) and the standard intervention group (n = 36). The intervention consists of compressive therapy in the volume reduction phase for lymphedema secondary to breast cancer. The Experimental Intervention Group will receive an adjustable compaction wrap (Read Wrap®) while the standard Intervention Group will be submitted to compressive bandaging and will be followed up on an outpatient basis, as per institutional routine, twice a week, for 30 days. The institutional protocol for the lymphedema reduction phase will be respected, in which the orthosis is used at home for as long as possible, with time off just for bathing and sleeping, in addition, skincare and therapeutic exercises for upper limbs must be performed daily. An orientation booklet and home exercises of the institutional routine will be delivered. During the first 30 days of treatment, all study participants will be accompanied by a telephone channel that will be made available for questions, guidance, and communications of adverse events, in addition to a therapeutic diary that will be delivered at the first consultation and collected after this period, destined to notify relevant information that considers the use of compressive therapy, such as facilities, difficulties and time of use, symptoms related to the arm and adverse effects that may arise, and to monitor adherence to exercises. The suspension of treatment before the anticipated end of therapy will occur when adverse effects are observed, such as an increase in limb volume greater than 10% from the last measurement, signs of dermatitis, associated skin, or allergy. The case will be evaluated by the physiotherapy team and, when necessary, by the medical team and the treated procedures will be adopted. Data collection will take place through the analysis of physical and electronic data, medical records, interviews, and physical examination. The interviews will be conducted through questionnaires produced by the researchers, in addition to validated questionnaires for the Brazilian population. The evaluations will take place in the outpatient clinic of the physiotherapy service of the hospital on the 1st, 7th, and 30th day of the intervention for immediate evaluation, and will be followed up to 1 year later, to verify the measures of long-term results. The analysis of the data will be descriptive and comparative of the intervention groups, about the selected variables and the main results, through the analysis of measures of central tendency, dispersion, and frequency distribution. The evaluation of the result will be carried out by intention of treatment, using linear and simple, and multiple logistic regression. For all analyzes, a 95% confidence interval will be considered.

Conditions

• Breast Cancer Related Lymphedema
• Lymphedema, Secondary
• Lymphedema of Upper Arm
• Breast Neoplasms

Interventions

Type	Name	Description
DEVICE	Adjustable Compression Wrap	The material will be delivered, adapted, and oriented for the daily use of the adjustable compression wrap (Ready Wrap®). The wrap allows for easy use because it is the pre-molded system in inelastic material with self-adjusting compressible components according to the size and shape of the upper limb. Due to its compression properties, it can be used as a therapy to control lymphedema. The material composition is: 61% Nylon, 33% Polyurethane, 6% Elastane (Spandex)). The institutional protocol for the control of the lymphedema phase will be respected, in which the orthosis is used at home for the longest period possible, with the only removal for bathing and sleeping; in addition, skincare and therapeutic exercises for the upper limbs should be performed daily.
DEVICE	Compression Bandage	Evaluation, skincare, compression bandaging, and guidance on therapeutic exercises for upper limbs. The material used for binding is tubular mesh, foam, elastic compression bandage. Therapy will be followed according to the institutional protocol for the lymphedema reduction phase, in which it will be reassessed twice a week for 30 days.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-10-30
• Completion: 2024-03-31
• First posted: 2021-06-22
• Last updated: 2024-10-04

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated device study