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| Name | Class |
|---|---|
| Canadian Breast Cancer Research Alliance | OTHER |
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The purpose of this study is to evaluate the efficacy, safety and impact on quality of life of decongestive lymphatic therapy (DLT) in women who have completed treatment for breast cancer and present with lymphedema.
This is a multicentre trial enrolling 100 patients randomized to receive conservative care for arm lymphedema (Canadian Guidelines) with or without decongestive lymphatic therapy performed by a professional who has received training and certification in the technique of lymphatic draining massage.
Duration: One year after the last patient is randomized.
Randomized patients receive either standard of care or standard of care plus DLT (five massage sessions per week for 4 consecutive weeks). Primary evaluation of all patients is recorded six weeks after randomization by measuring the affected limb and comparing with the unaffected one. There is an extended follow-up of one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Standard of Care plus Lymphatic massage (Decongestive Lymphatic Therapy) |
|
| 2 | No Intervention | Standard of Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymphatic Massage (Decongestive Lymphatic Therapy) (Arm 1) | Procedure | 20 weeks of lymphatic massage therapy by a certified LMT in the Vodder technique Elastic Compression Sleeve and GLove |
| Measure | Description | Time Frame |
|---|---|---|
| Percent reduction in excess arm volume as calculated from circumferential arm measurements | at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of arm function | Midtreatment,6,12 24,52 weeks | |
| Quality of life | Midtreament, 6 12,24,52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Dayes, MD | Ontario Clinical Oncology Group (OCOG) | Study Director |
| Tim Whelan, MD | McMaster University | Principal Investigator |
| Jim Julian, M. Math | McMaster University | Principal Investigator |
| Lyn Kligman, RN | London Regional Cancer Centre | Principal Investigator |
| Kathy Pritchard, MD | Sunnybrook Regional Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta | T6G1Z2 | Canada | ||
| Dr. Leon Richard Oncology Centre |
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|
| Moncton |
| New Brunswick |
| E1C 8X3 |
| Canada |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| Dr. H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Thunder Bay Regional Health Science Centre, Regional Cancer Centre | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Sunnybrook Regional Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008209 | Lymphedema |
| D000072656 | Breast Cancer Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017575 | Gloves, Protective |
| ID | Term |
|---|---|
| D011481 | Protective Clothing |
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D003020 | Clothing |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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