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

• ClinicalTrials.gov Identifier: NCT02992782
• Recruitment Status: Recruiting
• First Posted: December 14, 2016
• Last Update Posted: December 1, 2022
• Sponsor: University of Alberta
• Collaborator: Cross Cancer Institute
• Information provided by (Responsible Party): University of Alberta

Tracking Information

• First Submitted Date: December 10, 2016
• First Posted Date: December 14, 2016
• Last Update Posted Date: December 1, 2022
• Actual Study Start Date: June 1, 2017
• Estimated Primary Completion Date: July 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 10, 2016)

Arm Lymphedema Volume [ Time Frame: Change from baseline to 12 weeks ]

Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 24, 2019)

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

Original Secondary Outcome Measures (submitted: December 10, 2016)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management
• Official Title: Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Pilot Randomized Control Trial
• Brief Summary: 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Breast Neoplasm
• Lymphedema

Intervention

• Behavioral: Standard Care
  Home program of decongestive exercise and daily use of a compression sleeve
• Behavioral: Exercise and Compression Garment
  Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve
• Behavioral: Exercise and Adjustable Compression Wrap
  Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve

Study Arms

• 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.
  Intervention: Behavioral: Standard Care
• 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.
  Intervention: Behavioral: Exercise and Compression Garment
• 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.
  Intervention: Behavioral: Exercise and Adjustable Compression Wrap

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 24, 2019): 60
• Original Estimated Enrollment (submitted: December 10, 2016): 24
• Estimated Study Completion Date: September 30, 2023
• Estimated Primary Completion Date: July 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Margaret L McNeely, PhD; 780-248-1531; mmcneely@ualberta.ca

Contact: Mona Al Onazi, BSc; 780-492-6007; alonazi@ualberta.ca

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02992782
• Other Study ID Numbers: HREBA - CC 16-1026
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: On completion of the study, data will be made available through the University of Alberta Libraries Dataserve Network
• Time Frame: Not determined
• Access Criteria: Pending

• Current Responsible Party: University of Alberta
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alberta
• Original Study Sponsor: Same as current
• Collaborators: Cross Cancer Institute

Investigators

• Principal Investigator: Margaret L McNeely, PhD; University of Alberta

• PRS Account: University of Alberta
• Verification Date: November 2022