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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Women who have undergone breast cancer surgery may develop swelling of the arm on the side the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This study will examine the effect of a 12-week decongestive progressive resistance exercise with advanced compression on breast cancer related lymphedema. Our objective is to determine if breast cancer survivors are willing and able to wear advanced compression while exercising and if the combination will help to reduce their lymphedema. Twenty-four breast cancer survivors from Edmonton, Alberta will be enrolled in the one-year long study.

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.

What data supports the effectiveness of the treatment Exercise and Compression for Lymphedema?

Research shows that combining compression therapy with exercise can help reduce arm lymphedema (swelling due to fluid buildup) in patients. Additionally, using compression garments during exercise has been associated with improvements in lymphedema for women who have had breast cancer. ^{1 2 3 4 5}

How does the treatment for lymphedema in this trial differ from other treatments?

The treatment in this trial is unique because it combines exercise with compression therapy, which is not a standard approach for lymphedema. While compression is commonly used, the integration with controlled exercises using a special device is a novel method to potentially enhance treatment effectiveness. ^{1 3 5 6 7}

Research Team

Margaret L McNeely, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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.

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

Have contraindications related to wearing compression on the limb

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Synergic effect of compression therapy and controlled active exercises using a facilitating device in the treatment of arm lymphedema. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

Role of weight lost in breast cancer-related lymph. [2023]

3. Australia pubmed.ncbi.nlm.nih.gov

Compression use during an exercise intervention and associated changes in breast cancer-related lymphedema. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Putting evidence into practice: cancer-related lymphedema. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Lymphedema interventions: exercise, surgery, and compression devices. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

EFFECTS OF COMPRESSION ON LYMPHEDEMA DURING RESISTANCE EXERCISE IN WOMEN WITH BREAST CANCER-RELATED LYMPHEDEMA: A RANDOMIZED, CROSS-OVER TRIAL. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-Analysis of the Effects of Exercise for Those With Cancer-Related Lymphedema. [2018]