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Daily use of the Adjustable Compression Wrap on the upper limb with breast cancer-related lymphedema during phase 1 compression therapy.

Daily use of compression bandage on the upper limb with breast cancer-related lymphedema during phase 1 compression therapy.

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.

Adjustable Compression Wrap

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.

Compression Bandage

Anke Bergmann, PhD

Raul Denner Duarte

Raul Denner

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.

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.

Randomization will be by lot when the patient enters the study. Envelopes will be made available that will contain a code that determines the allocation of patients in the intervention group experimental or standard.

Due to the characteristics of the study, it will be blind only to the researcher responsible for analyzing the collected data.

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

Guided by self-reporting and professional evaluation according to the Common Terminology Criteria for Adverse Events (CTCAE).

Expenses with material, professional, travel and food for each participant will be researched and noted on a form for later analysis.

The main outcome is the change in the volume of the upper limb with lymphedema, which will be assessed through the perimeter of the circumference of the limb, and indirectly estimated the volume of the limb using the cone trunk formula.

Ultrasonography is used, a non-invasive method of capturing images of tissues through the emission of ultrasonic waves, through the evaluation of images obtained by the portable device, it will be possible to characterize the alteration of the dermoepidermal complex and the tissue. subcutaneous tissue of the upper limb with lymphedema. The report will be provided by a professional with experience in using the kinesiological ultrasound method.

The tempertature of the arm will be assessed by means of thermography. Thermography is a safe, non-invasive imaging method that determines the distribution of body surface temperatures according to the physiological and pathological condition of the tissues. Inflammation, metabolic changes in the subcutaneous tissue and changes in blood supply result in changes in the temperature gradient of the affected area. In this way, the different stages of lymphedema will be related to different patterns of temperature distribution. The body surface temperatures will be recorded by means of a thermal camera and will be taken in the orthostatic position, from the anterior and posterior portions of the limb, at a distance of 2m. Later, these thermometric images will be analyzed using proprietary software. The standard measurement used will be in degrees celsius (ºC).

Health-related quality of life will be assessed using 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30' (EORTC QLQ-C30). It is an instrument validated for our population, which scores from 0 to 100, the higher the value the better the quality of life will be.

The functionality of the upper limbs will be assessed by the 'Disabilities of the Arm, Shoulder and Hand Questionnaire' (DASH). It is a validated instrument for our population, consisting of 30 questions that assess the ability to perform certain activities in the last week, regardless of the upper limb used. The score ranges from 0 to 100, the higher the worse the functionality.

Hand grip strength will be assessed by the dynamometer for 3 attempts, being considered the best of the 3.

Instituto Nacional de Cancer, Brazil

Principal Investigator

Daily use of the adjustable compression wrap on the upper limb with breast cancer-related lymphedema during phase 2 of compressive therapy.

Daily use of the compressive sleeve on the upper limb with breast cancer-related lymphedema during phase 2 of compressive therapy

Delivery, adaptation and guidance for daily use of the Adjustable Compression Wrap. (Ready Wrap® allows for easy use because to be pre-molded system in inelastic material with self-adjusting compressible components according to the size and shape of the upper limb. Due to its compressive properties, it can be used as therapy to control lymphedema. The material composition is: 61% Nylon, 33% Polyurethane, 6% Elastane (Spandex)).

The institutional protocol for the lymphedema control phase will be respected, in which the orthosis is used at home for the longest possible period, with only removal for bathing and sleeping; furthermore, skin care and therapeutic exercises for the upper limbs must be performed daily.

Delivery, adaptation and guidance for daily use of the Compression sleeve. (Compression Sleeve is a mesh in the shape of a glove that provides compression on the fabrics needed to help control the volume of the limbs. Traditionally used for stage 2 of compressive therapy. The composition of the material is: 64% Nylon, 36% Elastane (Spandex) ).

The institutional protocol for the lymphedema control phase will be respected, in which the orthosis is used at home for the longest possible period, with only removal for bathing and sleeping; furthermore, skin care and therapeutic exercises for the upper limbs must be performed daily.

Compression Sleeve

This is a randomized clinical trial, in which the use of an Adjustable compression wrap as a compressive therapy to control the upper limb volume of with lymphedema women secondary to breast cancer will be investigated, in comparison to the use of a compression sleeve conventionally used. It is expected that Adjustable compression wrap will be more effective than standard treatment for the control of lymphedema, in addition to promoting a better quality of life and functionality for women.

This is a randomized clinical trial of medical devices in pivotal stage, simple blind, which aims to evaluate the effectiveness of the use of adjustable compression wrap in controlling the volume of the upper limb of women with lymphedema secondary to breast cancer. It will be carried out in a reference hospital in 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 stabilized lymphedema in the upper limb secondary to breast cancer and, therefore indicated phase 2 of compressive therapy. According to the sample calculation will be needed72 women to be randomly randomized in a 1: 1 ratio between the experimental intervention group (n = 36) and the standard intervention group (n = 36).

The Intervention consists of compressive therapy in the control phase for lymphedema secondary to breast cancer, in which the Experimental Intervention Group will receive a Adjustable compression wrap (Read Wrap®) while the Standard Intervention Group will receive a standard compressive sleeve for use in the upper limb with lymphedema, according to the institutional routine. The institutional protocol for the lymphedema control phase will be respected, in which the orthosis is used at home for the longest possible period, with only removal for bathing and sleeping; furthermore, skin care and therapeutic exercises for the upper limbs must be performed daily. One guidance booklet and home exercises of the institutional routine will be delivered . During the initial 30 days of treatment, all study participants will be able to be accompanied by a telephone channel that will be provided for questions, guidance and communications of adverse events, in addition to a therapeutic diary that will be delivered at the first appointment and collected after this period, designed to notify relevant information that they consider about 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 the volume of the limb greater than 10% of the last measurement, signs of dermatitis, skin infections or allergy. The case will be evaluated by the physiotherapy team and, when necessary, by the medical team and the necessary procedures will be adopted.

Data collection will take place through the analysis of physical and electronic medical records, interviews and physical examination. The interviews will consist of 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 and 30th day of the intervention for immediate evaluation, and will be followed up until 1 years later, to verify the long-term outcome measures.

The analysis of the data will be descriptive and comparative of the intervention groups, in relation to the selected variables and the main outcomes, through the analysis of measures of central tendency, dispersion and frequency distribution. Outcome assessment will be performed by intention to treat, using linear and logistic regression, simple and multiple. For all analyzes the 95% confidence interval will be considered.

Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema

Punctuated by self-report and professional inspection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjustable Compression Wrap Versus Compression Bandage Reduce to Breast Cancer-related Lymphedema	NCT04934098	Breast Cancer R... Lymphedema, Sec... Lymphedema of U... Breast Neoplasm...	Adjustable Comp... Compression Ban...	18 Years -	Instituto Nacional de Cancer, Brazil
Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema	NCT04881604	Breast Cancer R... Lymphedema, Sec... Lymphedema of U... Breast Neoplasm...	Adjustable Comp... Compression Sle...	18 Years -	Instituto Nacional de Cancer, Brazil
Adjustable Compression Wrap Versus Compression Bandage Reduce to Breast Cancer-related Lymphedema	NCT04934098	Breast Cancer R... Lymphedema, Sec... Lymphedema of U... Breast Neoplasm...	Adjustable Comp... Compression Ban...	18 Years -	Instituto Nacional de Cancer, Brazil
Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema	NCT04881604	Breast Cancer R... Lymphedema, Sec... Lymphedema of U... Breast Neoplasm...	Adjustable Comp... Compression Sle...	18 Years -	Instituto Nacional de Cancer, Brazil
Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema	NCT04881604	Breast Cancer R... Lymphedema, Sec... Lymphedema of U... Breast Neoplasm...	Adjustable Comp... Compression Sle...	18 Years -	Instituto Nacional de Cancer, Brazil

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