Exercise and Compression for Lymphedema

(DREAM Trial)

Overseen By Mona Al Onazi, BSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Chemotherapy, Radiotherapy, Metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of exercise and compression garments can reduce arm swelling in women with lymphedema after breast cancer surgery. Participants will try different compression methods alongside exercises to determine which is more effective. Women who have undergone breast cancer surgery and experience mild to moderate arm swelling lasting at least three months may be suitable candidates. The goal is to discover if these combined treatments can positively impact lymphedema management. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance lymphedema management for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must stop other lymphedema treatments like manual lymph drainage and intermittent pneumatic compression during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both types of compression used in the trial are safe and effective for managing lymphedema, which is swelling caused by a build-up of lymph fluid. Studies have found that the compression sleeve helps reduce swelling in the limbs and does not worsen lymphedema symptoms during exercise. Most people find these garments comfortable, especially if they have swelling in their legs, though some find it harder to use them on their arms.

For those using the adjustable compression wrap, research indicates it effectively controls swelling and works as well as other methods like multilayer bandages. Reports confirm that these wraps are safe and do not cause any major unwanted effects.

Overall, both treatments are considered safe and effective for managing lymphedema in breast cancer survivors, with good adherence from participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to manage lymphedema through exercise and compression techniques. Unlike current standard care, which typically involves non-resistive exercises and compression sleeves, this trial examines the effects of combining decongestive progressive resistance exercises with either a compression garment or an adjustable compression wrap. The unique aspect here is the integration of resistance exercises, which could potentially enhance lymphatic drainage and improve limb function more effectively. By investigating these new combinations, researchers hope to discover more efficient methods to alleviate symptoms and improve quality of life for those with lymphedema.

What evidence suggests that this trial's treatments could be effective for lymphedema?

Research shows that wearing a compression garment during exercise can help reduce arm swelling in women who have undergone breast cancer surgery. In this trial, one group will use a compression garment during exercise, while another group will use adjustable compression wraps. Studies suggest that using these garments in the first few months after surgery may lower the risk of developing lymphedema, a condition that causes swelling. Exercise itself helps move fluid in the body, which can also reduce swelling. For those using adjustable compression wraps, research indicates they are effective and comfortable, with most users willing to continue using them. Both methods aim to improve quality of life by reducing swelling and increasing movement. ^{6 7 8 9 10}

Who Is on the Research Team?

Margaret L McNeely, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for women who have had breast cancer surgery and are dealing with arm swelling (lymphedema) on the same side. They must be using a compression sleeve, not be receiving other lymphedema treatments during the study, and have chronic lymphedema for at least 3 months. Women with severe obesity, heart issues, infections in the limb, or undergoing cancer therapies cannot participate.

Inclusion Criteria

I have swelling in one arm or leg that is not too severe.

I agree to stop other lymphedema treatments during the study.

I have had surgery to remove lymph nodes due to my cancer.

Exclusion Criteria

I am currently undergoing or scheduled for cancer treatment.

Have contraindications related to wearing compression on the limb

I do not have any uncontrolled health issues that could affect study participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week decongestive progressive resistance exercise program with advanced compression

12 weeks

24 visits (in-person, twice weekly)

Extended Treatment

Participants continue the exercise program for an additional 12 weeks in a community-based fitness center or at home

12 weeks

Follow-up

Participants are monitored for changes in arm lymphedema volume, function, and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise and Adjustable Compression Wrap
• Exercise and Compression Garment
• Standard Care

Trial Overview The study tests if a 12-week exercise program combined with wearing advanced compression garments can reduce swelling from lymphedema in breast cancer survivors. Participants will either continue standard care or use an adjustable wrap or garment while exercising to see which method is more effective.

How Is the Trial Designed?

Group I: Exercise and Compression Garment Experimental Treatment 1 Intervention

Intervention will include having participants wear a compression sleeve during exercise. They will wear the sleeve while carrying out the decongestive progressive resistance exercise program and will continue wearing their day-time compression garment for at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 Weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness center or at home.

Group II: Exercise and Adjustable Compression Wrap Experimental Treatment 1 Intervention

Intervention will include having participants will be fitted for an adjustable compression wrap. They will be required to wear the adjustable compression wrap during the decongestive progressive resistance exercise program and will continue wearing their compression sleeve at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness centre or at home.

Group III: Standard Care Active Control 1 Intervention

Standard care Intervention: including a home program of therapeutic (decongestive) exercise, which will include active, non-resistive motion of the involved limb. Participants will perform the exercise once daily for about 10 minutes and will be required to wear their compression sleeve for at least 12 hours per day, each day of the week. After 24 weeks, they will be given the opportunity to take part in the decongestive progressive resistance exercise program and will be provided with an adjustable compression garment to use during exercise.

Standard Care is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Varenicline for:

• Smoking cessation

Approved in European Union as Champix for:

• Smoking cessation

Approved in Canada as Champix for:

• Smoking cessation

Approved in Japan as Champix for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Cross Cancer Institute

Collaborator

Trials

62

Recruited

19,200+

Published Research Related to This Trial

In a randomized controlled trial involving 20 women with lymphedema due to breast cancer treatment, combining compression therapy with active exercises significantly reduced arm size, indicating its efficacy in managing lymphedema.

The study showed a significant mean reduction in arm volume when exercises were performed with a compression sleeve (p-value < 0.007), highlighting the importance of compression in enhancing the effectiveness of physical activity for lymphedema management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergic effect of compression therapy and controlled active exercises using a facilitating device in the treatment of arm lymphedema. Godoy, Mde F., Pereira, MR., Oliani, AH., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11995056/

A randomized, controlled noninferiority study of adjustable ... Adjustable compression wraps showed fewer side effects, and 83.3% of participants indicated they would continue using them. No adverse events were attributed to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07109674

Adjustable Compression Wraps (ACW) in Lymphedema The objective of this study was to compare the effectiveness, physical functioning and comfort of 2 types inelastic compression: adjustable compression wrap ( ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X12000844

Prospective, randomized, controlled trial comparing the ... This prospective, randomized, controlled comparative study assessed the effectiveness of an ACW in the treatment of leg lymphedema, compared with the ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35379618/

Decongestive progressive resistance exercise with an ... ... adjustable compression wrap during exercise. The primary outcome is the percentage reduction in arm lymphoedema volume. Secondary outcomes ...

5. lymphoedemaeducation.com.au lymphoedemaeducation.com.au/wp-content/uploads/2017/06/3b.-A-review-of-the-evidence-for-adjustable-compression-wrap-devices.pdf

A review of the evidence for adjustable compression wrap ... Compression therapy is a key component in the effective management of people with lower limb problems associated with venous, lymphatic and fat disorders ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39119622/

Efficacy, safety of and adherence to adjustable ... Both compression therapies achieved satisfactory adherence, were safe, effective and equivalent for controlling limb volume in breast cancer-related lymphedema.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X25000484

A randomized, controlled noninferiority study of adjustable ... Adjustable compression wraps were noninferior to inelastic multilayer bandages with a mean difference in volume reduction of 9.45 mL (95% confidence interval − ...

8. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/02692155241270921?mi=ehikzz

A randomized controlled trial - Jéssica Malena Pedro da ... The primary outcome was the change in excess limb volume. Secondary outcomes included adherence, incidence of adverse events, functionality, ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8981291/

Decongestive progressive resistance exercise with an ... The primary outcome is the percentage reduction in arm lymphoedema volume. Secondary outcomes include bioimpedance analysis, muscular strength, shoulder range ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05022823

NCT05022823 | Exercise and Compression for Lymphedema The purpose of this study is to investigate the benefit of combining resistance exercise with use of a compression sleeve on arm lymphedema.