Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Breast Neoplasms

Lymphedema

Breast Cancer Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Weeks 1-12, Standard Care only (Compression Sleeve, daytime wear)

Weeks 1 - 12, Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered Compression Bandages.

Weeks 1 - 12, Standard care (day-time sleeve) plus night-time use of a custom-made Night-time Compression System Garment

Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered compression bandages.

Night-time compression bandages

Compression Sleeve, daytime wear

Standard Care plus night-time compression by a custom-made night time compression system garment.

Night-time Compression custom-made garment

Margaret McNeely, PhD

Lymphedema (significant arm swelling on the surgical side) is one of the most common complications following treatment for breast cancer. The impact of lymphedema is profound, resulting in negative self image, increased anxiety and poorer quality of life. In time, lymphedema can result in recurrent infections in the arm, functional impairment and pain. Approximately 21% of women who undergo breast cancer treatment develop lymphedema. Unfortunately this is a life-time condition which tends to worsen over time. Currently, treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the wearing of compression sleeves during the day for maintenance. This study hopes to show that the addition of night-time compression creates a measurable reduction in arm volume and that adding night-time compression to the standard care (daytime compression only) will produce improvements in quality of life for breast cancer survivors.

Lymphedema is a lifetime condition which tends to worsen over time, affecting roughly 21% of of treated breast cancer patients. An initial intensive rehabilitative treatment is usually prescribed to reduce the lymphedema, followed by a maintenance program using compression sleeves (Standard Care). However, compression sleeves are prescribed for daytime use only due to the potential tourniquet effect of the sleeve rolling up or bunching during the night.

Compression Bandages (short stretch, low elasticity) can be used at night but proper application takes 20-30 minutes, require skill to apply properly and are costly. Various types of night-compression system garments (NCSGs) have been designed as alternatives to Compression Bandages (CB).

The objectives of this study are to determine:

1. Whether the addition of night-time compression (using CB or NCSG) to standard care (daytime compression only) improves control of arm lymphedema.
2. Whether the use of NCSGs result in better outcomes in quality of life, sleep, treatment compliance and patient independence than use of Compression Bandages.

The hypotheses are that:

1. Standard care plus the addition of NCSG will provide statistically significant improvement in management of arm lymphedema volume compared to standard care alone at 12 weeks.
2. Standard care plus the addition of Compression Bandages will provide statistically significant improved management of arm lymphedema volume compared to standard care alone at 12 weeks.
3. Standard care plus the addition of NCSG will provide statistically significant benefit in quality of life, sleep and self-efficacy over standard care plus Compression Bandaging at 12 weeks.

Group 1: Standard care weeks 1 - 12 Group 2: Standard care plus night-time Compression Bandaging weeks 1 - 12 Group 3: Standard care plus night-time use of NCSG weeks 1 - 12

All three groups will adopt NCSG use after the 12 week assessments have been done (weeks 13 - 24).

Sample size = 40 participants per group, for a total of 120 patients at three sites.

Participants will be randomized in a 1:1:1 ratio to Standard, CB or NCSG using a secure central randomization service administered by the Clinical Trials Unit of the Cross Cancer Institute. Women enrolled in the study will be stratified by accruing site and by lymphedema severity (i.e. mild versus moderate lymphedema as per the classification criteria of the International Society of Lymphology).

Arm volume (by Perometer) and arm fluid (by Bioimpedance analysis) will be measured and compared to that of the unaffected arm. BIA measures the impedance of flow from a low alternating electrical current that is applied to the body through a skin electrode. BIA records impedance values for each limb and provides an index that correlates with quantitative measurements of volume increase in limb size seen in the arm with lymphedema. This measurement will provide information on extracellular fluid changes that complements the data on arm lymphedema volume. An Independent Assessor unaware of treatment allocation (blinded) will perform the measurements of arm volume using the perometer, bioimpedance analysis, and body weight at baseline, 6, 12, 18 and 24 weeks. The duration of the primary intervention will be 12 weeks. Following the 12-week intervention period, participants in the CB and standard care groups will be measured for a NCSG.

The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal observational design and provide an opportunity to examine factors related to long-term adherence to night-time compression. Lymphedema specific questionnaires and subject diary will be completed at 6, 12, 18 and 24 weeks to assess subject's Quality of Life, sleep disturbance, self-efficacy and treatment adherence.

Studying if Adding Night Compression to Standard Care Will Have Improved Control of Lymphedema in Breast Cancer Subjects

Night-time Compression for Breast Cancer Related Lymphedema (LYNC): A Randomized Controlled Efficacy Trial

All IPD that underlie results in a publication will be available via the University of Alberta's DATAVERSE platform.

Cross Cancer Institute

AHS Cancer Control Alberta

Neoplasm Metastasis

Postoperative Complications

Daily use of the Adjustable Compression Wrap on the upper limb with breast cancer-related lymphedema during phase 1 compression therapy.

Daily use of compression bandage on the upper limb with breast cancer-related lymphedema during phase 1 compression therapy.

The material will be delivered, adapted, and oriented for the daily use of the adjustable compression wrap (Ready Wrap®). The wrap allows for easy use because it is the pre-molded system in inelastic material with self-adjusting compressible components according to the size and shape of the upper limb. Due to its compression properties, it can be used as a therapy to control lymphedema. The material composition is: 61% Nylon, 33% Polyurethane, 6% Elastane (Spandex)). The institutional protocol for the control of the lymphedema phase will be respected, in which the orthosis is used at home for the longest period possible, with the only removal for bathing and sleeping; in addition, skincare and therapeutic exercises for the upper limbs should be performed daily.

Adjustable Compression Wrap

Evaluation, skincare, compression bandaging, and guidance on therapeutic exercises for upper limbs. The material used for binding is tubular mesh, foam, elastic compression bandage. Therapy will be followed according to the institutional protocol for the lymphedema reduction phase, in which it will be reassessed twice a week for 30 days.

Compression Bandage

Anke Bergmann, PhD

Raul Denner Duarte

Raul Denner

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.

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.

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 Bandage Reduce to Breast Cancer-related Lymphedema

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

Guided by self-reporting and professional evaluation according to the Common Terminology Criteria for Adverse Events (CTCAE).

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

Principal Investigator

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.

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

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.

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

Punctuated by self-report and professional inspection.

This group received Complex Decongestive Physiotherapy.

This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.

This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.

Decongestive Physiotherapy

This group received CDP as same protocol of active comparator. In addition, Kinesiotaping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.

Decongestive Physiotherapy plus taping

Gülbin Ergin, PhD

Didem Karadibak, Prof.

Tuğba Yavuzşen, Prof.

One of the most common conservative treatments of lymphoedema is Complex Decongestive Physiotherapy (CDP). The bandage is one of the most important components of the treatment process. The multilayer short-stretch bandage is used to maintain volume reduction and prevent lymph backflow caused by compression. However, some patients refuse or postpone treatment or show a lower compliance with compression bandaging.Kinesio® Tex tape (KT) is a new technique for managing lymphoedema in the field of physical and alternative therapy, and it may affect decongestion of lymphatic fluid accumulated under the skin. Some studies which showed that KT was an effective for patients with BCRL, it was applied on both the affected arm and anastomosis. One of these studies also reported that a significant reduction in limb volume in patients who were applied of the tape only to the affected arm. This significant effect could also be seen by applying KT only to the anastomosis. In literature, however, there is no evidence to support this theory. So the aim of this study is to determine the effectiveness of KT which was applied to anastomotic regions along with CDP in the management of BCRL.

Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema

Effectiveness of Kinesio® Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema: A Randomized Controlled Study

Limb size was quantified by using circumferential limb measurements. Measurements were taken with patients in a prone position and the arm abducted at 30°. The circumference was measured every 5cm, starting at the ulnar styloid and continuing 45cm proximally for both limbs. Limb volume was calculated for each segment by using the frustum formula. Frustum formula is a mathematical method for calculating limb volume based on the circumference measures, and this formula gives the result in milliliters. Limb measuring was carried out at the beginning of and after treatment (twenty sessions).

Dokuz Eylul University

Skin deterioration was expected due to bandage or taping, however, any skin allergy or wounds have not occurred in all patients.

This group received Complex Decongestive Physiotherapy.

Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.

This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.

Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.

Decongestive Physiotherapy Plus Taping

Total

Age, Continuous

Four patients in control group excluded from the study due to not completed the study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Studying if Adding Night Compression to Standard Care Will Have Improved Control of Lymphedema in Breast Cancer Subjects	NCT02187289	Breast Cancer Lymphedema	Night-time comp... Compression Sle... Night-time Comp...	-	AHS Cancer Control Alberta
Adjustable Compression Wrap Versus Compression Bandage Reduce to Breast Cancer-related Lymphedema	NCT04934098	Breast Cancer R... Lymphedema, Sec... Lymphedema of U... Breast Neoplasm...	Adjustable Comp... Compression Ban...	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
Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema	NCT03765996	Breast Cancer L... Compression Ban... Manual Lymphati...	Decongestive Ph... Decongestive Ph...	18 Years -	Dokuz Eylul University
Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema	NCT03765996	Breast Cancer L... Compression Ban... Manual Lymphati...	Decongestive Ph... Decongestive Ph...	18 Years -	Dokuz Eylul University
Adjustable Compression Wrap Versus Compression Bandage Reduce to Breast Cancer-related Lymphedema	NCT04934098	Breast Cancer R... Lymphedema, Sec... Lymphedema of U... Breast Neoplasm...	Adjustable Comp... Compression Ban...	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
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
Studying if Adding Night Compression to Standard Care Will Have Improved Control of Lymphedema in Breast Cancer Subjects	NCT02187289	Breast Cancer Lymphedema	Night-time comp... Compression Sle... Night-time Comp...	-	AHS Cancer Control Alberta

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