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

NCT ID: NCT04881604

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Adjustable Compression Wrap

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

Group Type: EXPERIMENTAL

Adjustable Compression Wrap

Intervention Type: DEVICE

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.

Compression Sleeve

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

Group Type: ACTIVE_COMPARATOR

Compression Sleeve

Intervention Type: DEVICE

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.

Interventions

Adjustable Compression Wrap

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.

Intervention Type: DEVICE

Compression Sleeve

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.

Intervention Type: DEVICE

Other Intervention Names

Compressive Mesh

Eligibility Criteria

Inclusion Criteria

1. Women

1. Age over 18 years

2. Undergo surgical treatment for breast cancer

3. Diagnosed with lymphedema in the upper limb stabilized for a period ≥6 months

4. Indicated the second phase of compressive therapy / treatment of lymphedema

Exclusion Criteria

1. Women with:

1. Bilateral lymphedema;

2. Lymphedema since the preoperative period;

3. Presence of phlogistic signs in the limb with lymphedema;

4. Treatment of lymphedema (phase 1) in the last three months;

5. Previous history of allergic reaction to the material used for compressive therapy;

6. Active regional or remote disease;

7. In chemotherapy or radiation therapy;

8. Functional changes in the upper limbs prior to the diagnosis of breast cancer;

9. Heart disease and decompensated systemic arterial hypertension; psychiatric, mental, neurological disorders or cognitive deficits that make it impossible to answer the questionnaires.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Cancer, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anke Bergmann

phD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anke Bergmann, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (INCA-BRAZIL)

Locations

Anke Bergmann

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

da Silva JMP, Araujo RDD, da Silva Santos FC, Fabro EAN, de Mello Pinto MV, de Aguiar SS, Thuler LCS, Bergmann A. Complex physical therapy employing self-adjusting garment (ReadyWrap(R)) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trial. Trials. 2023 Aug 22;24(1):549. doi: 10.1186/s13063-023-07460-4.

Reference Type: DERIVED

PMID: 37608354 (View on PubMed)

Other Identifiers

Stage 2 compression therapy

Identifier Type: -

Identifier Source: org_study_id