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Daily use of the adjustable compression wrap on the upper limb with breast cancer-related lymphedema during phase 2 of compressive therapy.

Daily use of the compressive sleeve on the upper limb with breast cancer-related lymphedema during phase 2 of compressive therapy

Delivery, adaptation and guidance for daily use of the Adjustable Compression Wrap. (Ready Wrap® allows for easy use because to be pre-molded system in inelastic material with self-adjusting compressible components according to the size and shape of the upper limb. Due to its compressive properties, it can be used as therapy to control lymphedema. The material composition is: 61% Nylon, 33% Polyurethane, 6% Elastane (Spandex)).

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.

Adjustable Compression Wrap

Delivery, adaptation and guidance for daily use of the Compression sleeve. (Compression Sleeve is a mesh in the shape of a glove that provides compression on the fabrics needed to help control the volume of the limbs. Traditionally used for stage 2 of compressive therapy. The composition of the material is: 64% Nylon, 36% Elastane (Spandex) ).

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.

Compression Sleeve

Anke Bergmann, PhD

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.

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.

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.

Due to the characteristics of the study, it will be blind only to the researcher responsible for analyzing the collected data.

Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema

Compressive Therapy by Adjustable Compression Garment (Ready Wrap®) in Breast Cancer-related Lymphedema: Randomized Clinical Trial

Punctuated by self-report and professional inspection.

Expenses with material, professional, travel and food for each participant will be researched and noted on a form for later analysis.

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.

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 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).

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 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.

Hand grip strength will be assessed by the dynamometer for 3 attempts, being considered the best of the 3.

Instituto Nacional de Cancer, Brazil

Mild Lymphedema: Only required to meet with the lymphedema physical therapist

Mild Lymphedema: Fitted for compression sleeve

Moderate lymphedema: Fitted with a compression sleeve

Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage

Worn overnight at least 5 nights of the week

Short-Stretch Compression Bandage

Alphonse G. Taghian, MD, PhD

Women who have been treated for breast cancer may be at risk for lymphedema or arm swelling. Currently, there are no clear treatment guidelines for lymphedema. One treatment method used to treat lymphedema is the use of compression sleeves to encourage the flow of lymph fluid out of the arms and prevent arm swelling in the future. Another treatment method is more intensive and involves wearing compression sleeves as well as special compression bandages overnight. It is unclear whether the use of compression with both sleeves and bandaging is more effective in treating lymphedema than the use of compression sleeves alone. The purpose of this research study is to evaluate the effectiveness of the use of compression garments in preventing or slowing the progression of lymphedema in breast cancer patients.

* Because no one knows which of the study options is best, participant's will be randomized into one of the study groups. Participants with mild lymphedema will be randomized into either Group 1A or Group 1B. Participants with moderate lymphedema will be randomized into either Group 2A or Group 2B.
* All study participants will meet with a lymphedema physical therapist to review daily shoulder range of motion exercises to help minimize their arm swelling. They will be asked to record their range of motion exercises and activities in a study treatment journal. Participants will bring their journal to each study visit (every 4 weeks).
* Group 1A will only be required to meet with the lymphedema physical therapist as described above.
* Group 1B and Group 2A will be fitted with a compression sleeve at their first lymphedema physical therapy visit. They will wear the sleeve for a minimum of 12 hours per day.
* Group 2B will also be fitted with a compression sleeve at their first lymphedema physical therapy visit and will wear the sleeve for a minimum of 12 hours per day. They will also be instructed to wear a short-stretch compression bandage that goes from the top of the hand to the armpit. They will be asked to wear this compression bandage during the night. The overnight compression bandage should be worn for at least 5 nights out of the week.
* Participants will come to the clinic every 4 weeks. The following tests and procedures will be performed: height and weight measurements; review of any side effects; arm volume measurements for both arms; questionnaire.

Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer

Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer: A Randomized Trial

Participants who are randomized to receive compression treatment will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC\<10%.Data was collected in study participants enrolled in Group 1A and Group 1B only (15 patients total), and the percentage of participants who experienced reduction in edema is reported below.

Participants who are randomized to receive compression treatment with/without night bandaging will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC\<10%. Data was collected in participants enrolled in Group 2A and 2B only (8 participants total), and the percentage of participants who experienced reduction in edema is reported below.

Symptoms were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. The responses were scored on a scale from 0-51, where higher score was associated with presence of more symptoms (0=no symptoms, 51 = most symptoms)

Fear avoidance behavior was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 7-28, where higher score was associated with higher level of fear of using arm (7= least fear level; 28= most fear level)

Quality of life was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 0-141, where higher score was associated with higher post-operative quality of life (0= worst; 141= best)

Upper extremity functions were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 19-95, where higher score was associated with more difficulty utilizing arm for daily activities (19 = least difficulty; 95 = most difficulty)

Surgical and radiation therapy risk factors for lymphedema (surgery to lymph nodes, radiation to lymph nodes), as well as risk factors unrelated to breast cancer treatment such as high BMI were collected upon medical record review

We recorded the number of participants who had low-level arm swelling, as defined by the Relative Volume Change (RVC) equation of \>5%-\<10%, at the time of their post-operative follow up to determine if women who had low-level arm swelling were more likely to develop lymphedema

National Cancer Institute (NCI)

Massachusetts General Hospital

Chief of Breast Service, Radiation Oncology

Group 1A

Mild Lymphedema: Fitted for compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Group 1B

Moderate lymphedema: Fitted with a compression sleeve

Compression Sleeve: Worn for a minimum of 12 hours per day

Group 2A

Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage

Compression Sleeve: Worn for a minimum of 12 hours per day

Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week

Group 2B

Total

Age, Categorical

Sex: Female, Male

This trial was terminated due to slow accrual and small number of subjects for whom data was collected (23 out of expected 334). Study did not reach statistical power to conduct detailed analysis, results should be interpreted with this in mind

Dr. Alphonse G Taghian, MD PhD

This outcome measure was compared between Group 1A (control) and Group 1B (compression garment). No data was collected for this outcome in Groups 2A and 2B

To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment

This outcome measure was compared between Groups 2A and 2B. No data was collected for Group 1A and 1B as this outcome does not apply to these groups

To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garments +/- Night Compression Bandaging for Moderate Volume Lymphedema Due to Breast Cancer Treatment

Median scores of the symptom-related questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.

To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema

Median scores for the fear avoidance behavior section on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.

To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema

Median scores for the quality of life questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.

To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema

Median scores for the upper extremity function questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.

To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema

The number and percentage of participants in each group who had at least 2 known risk factors for lymphedema is documented in the outcome measure data table below

To Identify the Number of Patients With Risk Factors Associated With the Onset of Lymphedema That Are Both Related and Unrelated to Treatment for Breast Cancer

Number and percentage of participants who had low-level arm swelling at their post-operative follow up are documented below

To Evaluate the Number of Patients With Low-level Arm Swelling in Order to Understand the Natural History of Lymphedema After Treatment for Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema	NCT04881604	Breast Cancer R... Lymphedema, Sec... Lymphedema of U... Breast Neoplasm...	Adjustable Comp... Compression Sle...	18 Years -	Instituto Nacional de Cancer, Brazil
Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema	NCT04881604	Breast Cancer R... Lymphedema, Sec... Lymphedema of U... Breast Neoplasm...	Adjustable Comp... Compression Sle...	18 Years -	Instituto Nacional de Cancer, Brazil
Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer	NCT00959985	Lymphedema Breast Cancer	Compression Sle... Short-Stretch C...	18 Years -	Massachusetts General Hospital
Adjustable Compression Wrap Versus Compression Sleeve to Control Breast Cancer-related Lymphedema	NCT04881604	Breast Cancer R... Lymphedema, Sec... Lymphedema of U... Breast Neoplasm...	Adjustable Comp... Compression Sle...	18 Years -	Instituto Nacional de Cancer, Brazil

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