Clinical trial NCT02992782: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Neoplasm
Lymphedema
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2016-12-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Arm Lymphedema Volume
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Bioimpedance Analysis
timeFrame: Change from baseline to 12 weeks
measure: Upper body strength
timeFrame: Change baseline to 12 weeks
measure: Lower body strength
timeFrame: Change baseline to 12 weeks
measure: Shoulder range of motion
timeFrame: Change baseline to 12 weeks
measure: Lymphedema International Classification of Functioning (LYMPH-ICF)
timeFrame: Change baseline to 12-weeks
measure: Rand Short-form (SF): 36
timeFrame: Change baseline to 12-weeks
measure: Godin Leisure-time Questionnaire
timeFrame: Change baseline to 12-weeks
measure: Body composition
timeFrame: Change baseline to 12-weeks
measure: Body Image
timeFrame: Change baseline to 12-weeks
measure: Tissue Composition
timeFrame: Change baseline to 12-weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta/ Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Margaret L McNeely, PhD
role: PRINCIPAL_INVESTIGATOR
References: