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Exercise and Compression for Lymphedema (DREAM Trial)

N/A

Waitlist Available

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection

Must not have

Are undergoing or are scheduled to receive chemotherapy or radiotherapy

Presents with limb infection/ cellulitis, deep vein thrombosis, or have active metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating the benefit of combining resistance exercise with use of a compression sleeve or wrap on arm lymphedema.

Who is the study for?

This trial is for women with a history of breast cancer who have undergone surgery and have mild to moderate unilateral arm lymphedema for at least 3 months. They must use a compression sleeve daily and agree not to use other lymphedema treatments during the study. Excluded are those currently receiving cancer treatment, with limb infections, deep vein thrombosis, active metastatic disease, or conditions that could affect participation.

What is being tested?

The study tests if resistance exercise combined with wearing a compression sleeve can benefit women with arm lymphedema after breast cancer surgery. Participants will follow a 'decongestive progressive resistance exercise' program while using either their usual compression sleeve or an adjustable wrap during workouts.

What are the potential side effects?

Potential side effects may include discomfort from wearing the compression garments and muscle soreness from the exercises. There might also be skin irritation under the garment or increased swelling if the garment doesn't fit properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to stop any special lymphedema treatments for 12 weeks.

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

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I have noticeable swelling in one arm due to lymphedema, meeting the specified volume differences.

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I am a woman who has had breast cancer.

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I am in the maintenance phase for my lymphedema treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving or scheduled for chemotherapy or radiotherapy.

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I have an infection in my limb, a blood clot, or cancer that has spread.

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I cannot wear compression garments due to poor blood flow or heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Lymphedema Arm Volume

Secondary study objectives

Change in Extracellular Fluid Volume

Change in Grip Strength

Change in Muscle Strength

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: DPRE + compression sleeve during exerciseExperimental Treatment3 Interventions

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

Group II: DPRE + AC garment during exerciseExperimental Treatment3 Interventions

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

Group III: Standard of CareActive Control2 Interventions

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

0 / 8Eligibility criteria met