Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management (NCT02992782) | Clinical Trial Compass
CompletedNot Applicable
Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management
Canada60 participantsStarted 2017-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Is a female with a history of breast cancer;
. Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection;
. 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;
. Has chronic lymphedema, defined as lymphedema that has been present for at least 3 months;
. Is in the lymphedema maintenance phase of conservative treatment;
. 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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. Are undergoing or are scheduled for chemotherapy, radiotherapy or biological therapy;
. Present with limb infection, deep vein thrombosis, cellulitis, or have active metastatic disease;
. Have any neurological, cognitive deficit or other uncontrolled health condition that may interfere with assessment and/or the progressive resistance exercise training intervention;
. Have any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;
. Have a body mass index (BMI) greater than 40 kg/m2.