Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management (DREAM)

Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Pilot Randomized Control 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphedema; Breast Neoplasm
• Intervention / Treatment: Behavioral: Standard Care; Behavioral: Exercise and Compression Garment; Behavioral: Exercise and Adjustable Compression Wrap

Detailed Description

Lymphedema is a swelling in the arm, chest wall and breast on the side of the breast cancer. Arm lymphedema develops as a result of breast cancer surgery and/ or radiation therapy. Compression therapy and exercise are commonly prescribed treatment to help reduce the arm swelling and to maintain the result. The exercise that is usually prescribed for lymphedema is called decongestive remedial exercise. It involves active, non-resisted movements that follow a specific order from proximal to distal and back proximally. The exercises start at the neck, move to the chest wall and then down the arm, and back.

Two different types of compression garments have been proposed to help reduce swelling when women are exercising. One compression garment is made with a stiffer, less elastic type of material and is called a "flat-knit" garment. The other garment, the "Adjustable Compression Wrap" is a garment with an adjustable elastic strapping system that helps to reinforce the compression on the arm. Recent research suggests that these specialized garments enhance the muscle pump effect on lymph flow; however, no research has been conducted to test whether this actually results in improvements in arm lymphedema volume.

Resistance exercise training helps to improve arm flexibility, strength, function, and quality of life in breast cancer survivors. Recent evidence has shown that breast cancer survivors with lymphedema, can safely perform resistance training (strength training), however, there is no impact (better or worse) on arm lymphedema volume.

To date, no studies have been performed combining all potential therapeutic approaches for lymphedema management: resistance exercise, a therapeutic decongestive exercise sequence, and compression therapy. Women in the experimental arms of this study will wear a compression garment when performing progressive resistance exercise that follows the decongestive sequence. We will examine the effect of the combined intervention on arm lymphedema volume, function and quality of life.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G4
      • University of Alberta/ Cross Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Is a female with a history of breast cancer;
2. Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection;
3. Has unilateral mild to moderate lymphedema of at least 200 ml or 10% inter-limb volume difference or a maximum of 40% and/or minimal volume difference of 100 ml or 5% in hand and forearm region;
4. Has chronic lymphedema, defined as lymphedema that has been present for at least 3 months;
5. Is in the lymphedema maintenance phase of conservative treatment;
6. 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);
7. Is agreeable to discontinuing other lymphedema treatments, including manual lymph drainage and intermittent pneumatic compression during the supervised intervention period of the study

Exclusion Criteria:

1. Are undergoing or are scheduled for chemotherapy, radiotherapy or biological therapy;
2. Present with limb infection, deep vein thrombosis, cellulitis, or have active metastatic disease;
3. Have any neurological, cognitive deficit or other uncontrolled health condition that may interfere with assessment and/or the progressive resistance exercise training intervention;
4. Have any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;
5. Have a body mass index (BMI) greater than 40 kg/m2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care; 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.	Behavioral: Standard Care; Home program of decongestive exercise and daily use of a compression sleeve
Experimental: Exercise and Compression Garment; 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.	Behavioral: Exercise and Compression Garment; Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve
Experimental: Exercise and Adjustable Compression Wrap; 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.	Behavioral: Exercise and Adjustable Compression Wrap; Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm Lymphedema Volume	Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)	Change from baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioimpedance Analysis	Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm	Change from baseline to 12 weeks
Upper body strength	One repetition maximum strength for bench press and seated row	Change baseline to 12 weeks
Lower body strength	One repetition maximum strength for leg press	Change baseline to 12 weeks
Shoulder range of motion	Range of motion measured with goniometer: forward flexion, abduction, external, internal and horizontal abduction movements	Change baseline to 12 weeks
Lymphedema International Classification of Functioning (LYMPH-ICF)	Lymphedema-specific quality of life	Change baseline to 12-weeks
Rand Short-form (SF): 36	General health-related quality of life	Change baseline to 12-weeks
Godin Leisure-time Questionnaire	Physical activity level in previous 4-week period	Change baseline to 12-weeks
Body composition	Body mass index as calculated by body weight and height metrics	Change baseline to 12-weeks
Body Image	Body Image and Relationship in past month	Change baseline to 12-weeks
Tissue Composition	Magnetic Resonance Imaging: fat, water and muscle mass	Change baseline to 12-weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Cross Cancer Institute
• Investigators: Principal Investigator: Margaret L McNeely, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): August 14, 2023
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: December 10, 2016
• First Submitted That Met QC Criteria: December 10, 2016
• First Posted (Estimated): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: HREBA - CC 16-1026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On completion of the study, data will be made available through the University of Alberta Libraries Dataserve Network
• IPD Sharing Time Frame: Not determined
• IPD Sharing Access Criteria: Pending

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No