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

NCT04934098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-10-04

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Principal Investigators

  • Anke Bergmann, PhD · National Cancer Institute (INCA-BRAZIL)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-10-30
Completion
2024-03-31
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04934098 on ClinicalTrials.gov