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| Name | Class |
|---|---|
| Hamilton Health Sciences Corporation | OTHER |
| St. Joseph's Healthcare Hamilton | OTHER |
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The purpose of this pilot study is to compare a new surgical technique (axillary reverse mapping) to standard axillary surgery in patients diagnosed with invasive or in situ breast cancer.
Lymphedema is a major chronic morbidity that occurs in patients undergoing treatment for breast cancer (BC). Surgery for BC includes axillary surgery with either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Lymphedema occurs due to removal or disruption of lymphatic drainage of the arm that overlaps with drainage of the breast. The risk of lymphedema increases significantly with adjuvant radiation. Axillary reverse mapping (ARM) is a technique where blue dye is injected into the upper arm at surgery, allowing direct visualization of arm lymphatics and nodes during either SLNB or ALND. This allows preservation of arm lymphatics unless there is suspicion of metastatic disease in ARM lymphatics or if the ARM node is/are also the sentinel lymph node. Studies to date have largely been observational cohort studies, and mainly with low risk patients undergoing SLNB only. There is only one published randomized controlled trial, and this included only patients undergoing modified radical mastectomy.Our proposal is a prospective randomized pilot study. The study population includes patients undergoing axillary surgery (SLNB with mastectomy or ALND with either BCS or mastectomy or completion ALND after positive SLNB). The intervention group will undergo ARM; the control will undergo standard surgical treatment. Both groups will undergo standardized baseline and postoperative arm measurements and patients will complete symptom and quality of life questionnaires. The purpose is to determine the feasibility of the ARM technique, its accuracy in identifying and sparing arm lymphatics, and its ability to reduce the risk of lymphedema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| axillary reverse mapping | Experimental | Axillary reverse mapping and sentinel lymph node biopsy (ARM/SLNB) or Axillary reverse mapping and axillary lymph node dissection (ARM/ALND) |
|
| standard axillary surgery | Active Comparator | The control group will have standard sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| axillary reverse mapping (ARM) | Procedure | ARM/SLNB: patient will be injected with technetium-99 radiolabelled colloid (Tc-99) into the subareolar area of breast, then 1-2 mls of blue dye (patent blue dye) injected subcutaneously into the medial ipsilateral arm, just proximal to the medial epicondyle of the elbow, at the start of the surgical procedure. the SLN(s) will be identified ("hot node") and removed, and any blue lymph nodes and lymphatics will be preserved intact, and only removed or disrupted if there is 'crossover" (i.e. the blue node is also the SLN) or if clinically suspicious for metastatic disease. ARM/ALND: 1-2 mls of blue dye will be injected subcutaneously into the medial ipsilateral arm at the start of the surgical procedure. Surgeons will perform a standard level I and II axillary dissection and any blue lymph nodes or lymphatics will be preserved intact, and only removed or disrupted if blue nodes are suspicious for metastatic disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphedema | Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema | Change from baseline to 6 months post-operative |
| Lymphedema | Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema | Change from baseline to 12 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC-QLQ-C30 | General quality of life | Change from baseline to 6 months post-operative |
| EORTC-QLQ-C30 | General quality of life | Change from baseline to 12 months post-operative |
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Inclusion Criteria: women diagnosed with invasive breast cancer or ductal carcinoma in situ receiving the following treatment:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Lovrics, MD | McMaster University | Principal Investigator |
| Nicole Hodgson, MD, MSc | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada | ||
| Juravinski Hospital and Cancer Centre |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Standard axillary surgery (SLNB or ALND) | Procedure | The control group will have standard SLNB or ALND surgery without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected). |
|
| Disabilities of the Arm and Shoulder and Hand (DASH) | arm symptoms and disabilities | Change from baseline to 6 months post-operative |
| Disabilities of the Arm and Shoulder and Hand (DASH) | arm symptoms and disabilities | Change from baseline to 12 months post-operative |
| Post-operative complications | infection, hematoma, problems with wound healing | 30 days post-op |
| Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1 | arm symptoms and pain | Change from baseline to 6 months post-operative |
| Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1 | arm symptoms and pain | Change from baseline to 12 months post-operative |
| Hamilton |
| Ontario |
| L8V 5C2 |
| Canada |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |