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

NCT04881604 | Completed DMC FDA Device

• 1 other identifier: Stage 2 compression therapy
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

breast cancer lymphedema; compression bandages

Outcome Measures

Primary Outcomes (1)

• Arm volume

  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.

  Assessment of arm volume will be on the before (1st day), 30 days, 6 months and 1 year after enrollment.

Secondary Outcomes (5)

• Tissue characteristics (fibrosis) of the upper limb with lymphedema

  The evaluation of the tissue characteristics of the arm will be before (1st day), 30 days, 6 months and 1 year after enrollment.

• Tissue temperature of the upper limb with lymphedema

  The tissue temperature of the arm will be before (1st day), 30 days, 6 months and 1 year after enrollment.

• Health-related quality of life

  The evaluation of the Health-related quality of life will be before (1st day), 30 days, 6 months and 1 year after enrollment.

• Upper limb functionality

  The evaluation of the Upper limb functionality will be before (1st day), 30 days, 6 months and 1 year after enrollment.

• Handgrip strength

  The handgrip strength assessment will be before (1st day), 30 days, 6 months and 1 year after enrollment.

Other Outcomes (2)

• Adverse effects of treatment

  Daily documents during the first 30 days of the intervention. And at 6 and 12 months follow-up.

• Treatment costs

  Total cost of each therapy within 12 months of follow-up.

Study Arms (2)

Adjustable Compression Wrap

EXPERIMENTAL

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

Device: Adjustable Compression Wrap

Compression Sleeve

ACTIVE COMPARATOR

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

Device: Compression Sleeve

Interventions

Adjustable Compression Wrap 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.

Adjustable Compression Wrap

Compression Sleeve 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.

Also known as: Compressive Mesh

Compression Sleeve

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Women
• Age over 18 years
• Undergo surgical treatment for breast cancer
• Diagnosed with lymphedema in the upper limb stabilized for a period ≥6 months
• Indicated the second phase of compressive therapy / treatment of lymphedema

You may not qualify if:

• \. Women with:
• Bilateral lymphedema;
• Lymphedema since the preoperative period;
• Presence of phlogistic signs in the limb with lymphedema;
• Treatment of lymphedema (phase 1) in the last three months;
• Previous history of allergic reaction to the material used for compressive therapy;
• Active regional or remote disease;
• In chemotherapy or radiation therapy;
• Functional changes in the upper limbs prior to the diagnosis of breast cancer;
• Heart disease and decompensated systemic arterial hypertension; psychiatric, mental, neurological disorders or cognitive deficits that make it impossible to answer the questionnaires.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Anke Bergmann

Rio de Janeiro, Rio de Janeiro, 20231050, Brazil

Location

Related Publications (1)

• 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.

  PMID: 37608354 DERIVED

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema; Neoplasm Metastasis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anke Bergmann, PhD

  National Cancer Institute (INCA-BRAZIL)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the characteristics of the study, it will be blind only to the researcher responsible for analyzing the collected data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phD

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 11, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)