Status:
COMPLETED
Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Conditions:
Breast Cancer Related Lymphedema
Lymphedema, Secondary
Eligibility:
FEMALE
18+ years
Phase:
NA
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 wi...
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 t...
Eligibility Criteria
Inclusion
- 1\. 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
Exclusion
- 1\. 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04881604
Start Date
June 1 2021
End Date
March 31 2023
Last Update
September 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Anke Bergmann
Rio de Janeiro, Rio de Janeiro, Brazil, 20231050