Exercise and Compression for Lymphedema
(DREAM Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMargaret L McNeely, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alberta

No Placebo Group

Approved in 5 Jurisdictions

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.

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.

+4 more

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

+2 more

Participant Groups

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.

3Treatment groups

Experimental Treatment

Active Control

Group I: Exercise and Compression GarmentExperimental Treatment1 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 WrapExperimental Treatment1 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 CareActive Control1 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, Australia for the following indications:

🇺🇸 Approved in United States as Varenicline for: