Clinical trial NCT04934098: Adjustable Compression Wrap Versus Compression Bandage Reduce to 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: 2021-06-22
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 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.

Detailed description: This is a randomized clinical trial, simple blind, which aims to evaluate the effectiveness of the use of self-adjusting compression garments (Read Wrap®) in reducing the volume of the upper limb of women with lymphedema secondary to breast cancer. It will be carried out in a referral hospital for 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 lymphedema in the upper limb after surgical treatment for breast cancer for more than 6 months, indicating phase 1 of compressive therapy. According to the sample calculation, 72 women will be needed to be randomly randomized in a 1: 1 ratio among the experimental intervention group (n = 36) and the standard intervention group (n = 36). The intervention consists of compressive therapy in the volume reduction phase for lymphedema secondary to breast cancer. The Experimental Intervention Group will receive an adjustable compaction wrap (Read Wrap®) while the standard Intervention Group will be submitted to compressive bandaging and will be followed up on an outpatient basis, as per institutional routine, twice a week, for 30 days. The institutional protocol for the lymphedema reduction phase will be respected, in which the orthosis is used at home for as long as possible, with time off just for bathing and sleeping, in addition, skincare and therapeutic exercises for upper limbs must be performed daily. An orientation booklet and home exercises of the institutional routine will be delivered. During the first 30 days of treatment, all study participants will be accompanied by a telephone channel that will be made available for questions, guidance, and communications of adverse events, in addition to a therapeutic diary that will be delivered at the first consultation and collected after this period, destined to notify relevant information that considers 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 limb volume greater than 10% from the last measurement, signs of dermatitis, associated skin, or allergy. The case will be evaluated by the physiotherapy team and, when necessary, by the medical team and the treated procedures will be adopted.

Data collection will take place through the analysis of physical and electronic data, medical records, interviews, and physical examination. The interviews will be conducted through 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, 7th, and 30th day of the intervention for immediate evaluation, and will be followed up to 1 year later, to verify the measures of long-term results. The analysis of the data will be descriptive and comparative of the intervention groups, about the selected variables and the main results, through the analysis of measures of central tendency, dispersion, and frequency distribution. The evaluation of the result will be carried out by intention of treatment, using linear and simple, and multiple logistic regression. For all analyzes, a 95% confidence interval will be considered.

Eligibility criteria: Inclusion Criteria:

* 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:

* 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 events
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
Study officials:
affiliation: National Cancer Institute (INCA-BRAZIL)
name: Anke Bergmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: