Breast Neoplasms Clinical Trial
Official title:
Compressive Therapy by Adjustable Compression Garment (Ready Wrap®) in Breast Cancer-related Lymphedema: Randomized Clinical Trial
Verified date | September 2023 |
Source | Instituto Nacional de Cancer, Brazil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | March 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Anke Bergmann | Rio De Janeiro | RJ |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cancer, Brazil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse effects of treatment | Punctuated by self-report and professional inspection. | Daily documents during the first 30 days of the intervention. And at 6 and 12 months follow-up. | |
Other | Treatment costs | Expenses with material, professional, travel and food for each participant will be researched and noted on a form for later analysis. | Total cost of each therapy within 12 months of follow-up. | |
Primary | 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 | Tissue characteristics (fibrosis) of the upper limb with lymphedema | 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 evaluation of the tissue characteristics of the arm will be before (1st day), 30 days, 6 months and 1 year after enrollment. | |
Secondary | Tissue temperature of the upper limb with lymphedema | 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). | The tissue temperature of the arm will be before (1st day), 30 days, 6 months and 1 year after enrollment. | |
Secondary | Health-related quality of life | 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 evaluation of the Health-related quality of life will be before (1st day), 30 days, 6 months and 1 year after enrollment. | |
Secondary | Upper limb functionality | 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. | The evaluation of the Upper limb functionality will be before (1st day), 30 days, 6 months and 1 year after enrollment. | |
Secondary | Handgrip strength | Hand grip strength will be assessed by the dynamometer for 3 attempts, being considered the best of the 3. | The handgrip strength assessment will be before (1st day), 30 days, 6 months and 1 year after enrollment. |
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