Clinical trial NCT04881604: Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema
Official title: Compressive Therapy by Adjustable Compression Garment (Ready Wrap®) in Breast Cancer-related Lymphedema: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Related Lymphedema
Lymphedema, Secondary
Lymphedema of Upper Arm
Breast Neoplasms
Keywords: breast cancer lymphedema
compression bandages
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
First posted: 2021-05-11
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Arm volume
timeFrame: Assessment of arm volume will be on the before (1st day), 30 days, 6 months and 1 year after enrollment.
Secondary outcomes:
measure: Tissue characteristics (fibrosis) of the upper limb with lymphedema
timeFrame: The evaluation of the tissue characteristics of the arm will be before (1st day), 30 days, 6 months and 1 year after enrollment.
measure: Tissue temperature of the upper limb with lymphedema
timeFrame: The tissue temperature of the arm will be before (1st day), 30 days, 6 months and 1 year after enrollment.
measure: Health-related quality of life
timeFrame: The evaluation of the Health-related quality of life will be before (1st day), 30 days, 6 months and 1 year after enrollment.
measure: Upper limb functionality
timeFrame: The evaluation of the Upper limb functionality will be before (1st day), 30 days, 6 months and 1 year after enrollment.
measure: Handgrip strength
timeFrame: The handgrip strength assessment will be before (1st day), 30 days, 6 months and 1 year after enrollment.
Other outcomes:
measure: Adverse effects of treatment
timeFrame: Daily documents during the first 30 days of the intervention. And at 6 and 12 months follow-up.
measure: Treatment costs
timeFrame: Total cost of each therapy within 12 months of follow-up.
Locations:
city: Rio De Janeiro
country: Brazil
facility: Anke Bergmann
state: RJ
Study officials:
affiliation: National Cancer Institute (INCA-BRAZIL)
name: Anke Bergmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: