Compression sleeve, worn during exercise for Lymphedema

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cross Cancer Institute, Edmonton, Canada
Lymphedema+3 More
Compression sleeve, worn during exercise - Device
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

Exercise and Compression for Lymphedema

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Eligible Conditions

  • Lymphedema
  • Breast Cancer Related Lymphedema

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Compression sleeve, worn during exercise will improve 1 primary outcome and 8 secondary outcomes in patients with Lymphedema. Measurement will happen over the course of Up to 24 weeks.

Up to 24 weeks
Change in Extracellular Fluid Volume
Change in Grip Strength
Change in Lymphedema Arm Volume
Change in Muscle Strength
Change in Shoulder Range of Motion
Exercise and Compression Adherence
Health-Related Quality of Life (Lymph-ICF)
Health-Related Quality of Life (SF-36)
Physical Activity Level

Trial Safety

Trial Design

3 Treatment Groups

Standard of Care
1 of 3
DPRE + AC garment during exercise
1 of 3
DPRE + compression sleeve during exercise
1 of 3
Active Control
Experimental Treatment

This trial requires 40 total participants across 3 different treatment groups

This trial involves 3 different treatments. Compression Sleeve, Worn During Exercise is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

DPRE + AC garment during exerciseGroup C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day).
DPRE + compression sleeve during exerciseGroup B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day)
Standard of CareGroup A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 weeks for reporting.

Closest Location

Cross Cancer Institute - Edmonton, Canada

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Is a female with a history of breast cancer;
Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection;
Has unilateral mild to moderate BCRL of at least 200 ml inter-limb volume difference or regional lymphedema: defined as a minimal volume difference of 100 ml in a segment of the arm (e.g. hand and forearm region, elbow and upper arm);
Has chronic lymphedema, defined as lymphedema that has been present for at least 3 months;
Is in the lymphedema maintenance phase of conservative treatment;
Uses a well fitted compression sleeve (not older than 1 month) and is agreeable to wear the sleeve for a minimum of 12 hours per day (providing a minimum of 30 mm Hg of pressure);
Is agreeable to discontinuing other lymphedema treatments that are beyond standard care, including manual lymph drainage and intermittent pneumatic compression during the 12-week RCT period of the study.

Patient Q&A Section

What is lymphedema?

"Lymphedema occurs commonly among women with cancer and other diseases affecting the body's tissue, especially after surgical removal of the axilla. The condition is common, and it can cause significant disability and distress. Breast augmentation is the most common indication for surgical reconstruction." - Anonymous Online Contributor

Unverified Answer

Can lymphedema be cured?

"Although lymphedema does not cure, many people feel that improvements in their physical function is equivalent to the improvements in their quality of life that may occur if lymphedema is managed." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphedema?

"Treatments for lymphedema should be determined by an orthopedic surgeon based on the severity of disease and lifestyle, and a lymphatic block should be considered as the treatment with the highest likelihood of cure. In patients with lymphedema, the limb can be immobilized for up to six weeks after the block unless pain, edema, and discomfort have been reduced with conservative treatment. Then the limbs can be actively stretched at two-week intervals based on patient compliance and the type and severity of disease. There are three to five years following lymphatic block during which time the treatment should be monitored to minimize the chances of recurrence of lymphedema." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphedema?

"The findings are limited by study design and need to be confirmed in prospective studies. Most study findings are consistent with the use of the LYMPEDP questionnaire, rather than a more direct measurement of swelling." - Anonymous Online Contributor

Unverified Answer

How many people get lymphedema a year in the United States?

"Lymphedema was more frequent in women than in men. The most common site of Lymphedema was the lower limbs (95%), more common in men (43%) than in women (15%). The incidence of Lymphedema was 4.8 per thousand in the United States. Lymphedema was probably more common in the past. Lymphedema may be a public health problem in the United States." - Anonymous Online Contributor

Unverified Answer

What causes lymphedema?

"Lymphedema is a symptom of several syndromes, and can be caused by injury or trauma in childhood, or as a complication of diseases such as cancer, or due to genetic disorders. There is currently insufficient evidence to support the usefulness of specific treatment in the prevention of the condition. In the context of cancer treatment, lymphedema has been shown to affect approximately 5% to 10% of patients. In the context of surgery, lymphovenous fistula can be prevented only in a minority of patients. Further research to determine the effectiveness of lymphedema treatment programmes is indicated." - Anonymous Online Contributor

Unverified Answer

Does adjustable compression (ac) garment, worn during exercise improve quality of life for those with lymphedema?

"ACG may improve mobility and QoL for those with lymphedema when worn during exercise. Results from a recent paper support the use of ACG over the use of elastic stockings for people with lymphedema." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lymphedema?

"The survival rate is about 50% for lymphedema patients when the treatment is effective. The longer a Lymphedema duration > 6 months, the lower the survival rate. Lymphoedema survivors do suffer from many chronic problems such as limb pain, muscle atrophy, reduced fat weight and osteoarthritis. Lymphoedema survivors require close surveillance over their lymphoedema status to determine effectiveness of the treatment strategy. The treatment for the first lymphedema is mainly conservative. Lymphatic drainage (manual lymphatic drainage or MLD) should be the first intervention, combined with compression garments, exercise, and diet adjustments." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving adjustable compression (ac) garment, worn during exercise?

"This pilot study confirms that in people with chronic lymphedema, when a garment (ac) is worn during exercise and the body position is controlled, limb edema is reduced significantly." - Anonymous Online Contributor

Unverified Answer

Has adjustable compression (ac) garment, worn during exercise proven to be more effective than a placebo?

"We found no convincing evidence of a clinical benefit of ACG (as compared with ACG-placebo) on leg swelling in patients with lymphedema, and that discomfort was greater in patients wearing an ac garment. Recent findings of our meta-analysis add to the general concern about the efficacy of ACG. Recent findings suggest it may be beneficial to recommend ACG during exercise, however, because of the risk and discomfort, a more personalized and individualized approach may be prudent." - Anonymous Online Contributor

Unverified Answer

Is adjustable compression (ac) garment, worn during exercise typically used in combination with any other treatments?

"There were no differences between the group with garments and the group without garments. Although a significant difference in HR in both the groups showed a decrease. There were no differences in resting HR between groups. The adjustable compression gaiters did not seem to improve muscle strength in upper limb." - Anonymous Online Contributor

Unverified Answer

What does adjustable compression (ac) garment, worn during exercise usually treat?

"Compression garments as used in this study (AC garment) had no effect on a patient's leg swelling when compared to a patient on a standard (AAC) garment. It was concluded that adjusting the garment was not a valuable adjunct to compression garments unless it can be proven that compression garments cause less swelling and greater range of motion than AC garments." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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