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

Postoperative Complications

Group A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)

Group B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day)

Group C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day).

Participants wear their daytime compression sleeve during the DPRE program.

Compression sleeve, worn during exercise

Participants wear an Adjustable Compression (AC) garment during the DPRE program. Participants will be fitted for an Adjustable Compression garment and instructed in its application by a physical therapist.

Adjustable Compression (AC) garment, worn during exercise

Compression sleeve worn for at least 12 hours per day, seven days a week.

Compression sleeve, daytime wear

Supervised DPRE exercise program, twice a week for 12 weeks. Exercises will be individualized and offered in a group-based format.

After the 12-week intervention, participants will continue the same program (independently) twice weekly for an additional 12 weeks at home or in a community-based fitness center or attend supervised group exercise sessions virtually.

Decongestive Progressive Resistance Exercise program

Participants are provided with a home exercise program that follows the decongestive exercise sequence and instructed to perform the exercise sequence once daily for a 10-15 minute period.

Home exercise program

The purpose of this study is to investigate the benefit of combining resistance exercise with use of a compression sleeve on arm lymphedema. In the study, participants will be taught a resistance exercise that follows the decongestive exercise sequence. This program is called "decongestive progressive resistance exercise" (DPRE). To evaluate the benefit from use of a compression garment on the arm. Some participants will wear their usual compression sleeve during exercise and others will use an adjustable compression wrap. The investigators hope to see if this type of combined program is helpful for women with lymphedema. The investigators also want to see if there are benefits from the addition of use of an adjustable compression wrap during exercise over use of a regularly prescribed compression sleeve.

Exercise and Compression for Lymphedema

Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Randomized Control Trial

Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).

Bioimpedance analysis (BIA) is specially designed to estimate extracellular fluid volume in the limb. BIA measures the impedance ratio of the affected and unaffected limb and the resulting calculated index provides an estimate of extracellular fluid volume.

Muscle strength will be assessed with the one-repetition maximum (1-RM) method for bench press, leg press, and seated row. The 1-RM is the highest weight that can be lifted once using proper form, a smooth motion and without pain or other symptoms.

The Jamar hydraulic hand dynamometer will be used to measure grip strength.

Shoulder range of motion (ROM) will be measured using plastic goniometer and each arm will be measured separately for flexion, abduction, internal, external rotation, and horizontal abduction.

The Lymphedema Functioning, Disability, and Health (Lymph-ICF) questionnaire consists of 29 questions related to functional impairments, activity limitations, and participation restrictions in patients with upper limb lymphedema.The total score of the Lymph-ICF on the five areas ranges from 0 to 100, with a score of 0 meaning no impact and higher scores indicative of worse function or negative impact.

The Rand Short Form-36 Version 2 (SF-36) questionnaire is comprised of 36 questions that aim to evaluate the following eight models of HRQOL: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality/energy, social functioning, role limitations due to emotional problems, and general mental health.

The Godin leisure-time exercise questionnaire (GLTEQ) will be used to assess the physical activity level. The Godin questionnaire is a self reported measure of the average duration and frequency of strenuous (heart beats rapidly), moderate (not exhausting), and mild activities (minimal effort), resistance training, and flexibility training exercise.

Participants will be asked to record their adherence to their assigned exercise and compression intervention program using a daily diary.The adherence diary will collect details on exercise sessions performed each day, including sets, repetitions, and resistance weight, as well as use of the assigned compression sleeve (i.e. use of the garment during exercises and number of hours per day and days per week the compression sleeve is worn).

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
Exercise and Compression for Lymphedema	NCT05022823	Breast Cancer R...	Compression sle... Adjustable Comp... Compression sle... Decongestive Pr... Home exercise p...	18 Years -	AHS Cancer Control Alberta
Exercise and Compression for Lymphedema	NCT05022823	Breast Cancer R...	Compression sle... Adjustable Comp... Compression sle... Decongestive Pr... Home exercise p...	18 Years -	AHS Cancer Control Alberta
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

Spots Global Cancer Trial Database for compression sleeve, daytime wear