A Pilot Randomized Controlled Trial Comparing the Axillary Reverse Mapping (ARM) Technique to Standard Axillary Surgery in Breast Cancer Patients.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Invasive Breast Cancer
- Sponsor
- McMaster University
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Lymphedema
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Peter Lovrics
Principal Investigator
McMaster University
Eligibility Criteria
Inclusion Criteria
- •women diagnosed with invasive breast cancer or ductal carcinoma in situ receiving the following treatment:
- •mastectomy and sentinel lymph node biopsy
- •breast conserving surgery or mastectomy and axillary lymph node dissection
- •completion axillary lymph node dissection after positive sentinel lymph node biopsy
- •cases receiving neo-adjuvant therapy (chemotherapy or hormonal therapy) who are having axillary lymph node dissection as part of their surgical treatment -
Exclusion Criteria
- •males with breast cancer
- •women less than 18 years of age
- •known allergic reaction to patent blue dye
- •previous radiation therapy to affected side
- •clinical N2/N3 disease -
Outcomes
Primary Outcomes
Lymphedema
Time Frame: Change from baseline to 12 months post-operative
Arm circumference measurements of both arms. An arm volume difference of \> 10% will be considered clinically significant lymphedema
Secondary Outcomes
- EORTC-QLQ-C30(Change from baseline to 12 months post-operative)
- Disabilities of the Arm and Shoulder and Hand (DASH)(Change from baseline to 12 months post-operative)
- Post-operative complications(30 days post-op)
- Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1(Change from baseline to 12 months post-operative)