Preventing Lymphedema in Axillary Lymph Node Dissection
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/27/2018 |
Start Date: | April 10, 2018 |
End Date: | February 1, 2023 |
Contact: | Sheri Ramaker, R.N. |
Email: | ramaker.sheri@mayo.edu |
Phone: | 507-538-6984 |
Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass
The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous
bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and
severity of post-operative lymphedema of the arm.
bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and
severity of post-operative lymphedema of the arm.
All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization
will determine which of these subjects will have the ARM with LVB and which subjects will
have the ALND without this technique. As a baseline, all subjects will have the circumference
of their arms measured and complete a questionnaire about lymphedema. Performing the
measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after
surgery.
will determine which of these subjects will have the ARM with LVB and which subjects will
have the ALND without this technique. As a baseline, all subjects will have the circumference
of their arms measured and complete a questionnaire about lymphedema. Performing the
measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after
surgery.
Inclusion Criteria
- Patients scheduled to undergo an axillary lymph node dissection
- Patients who in the surgeon's judgement are at high risk to convert to an axillary
lymph node dissection based intraoperative findings
- English speaking
Exclusion Criteria
- Prior ipsilateral axillary lymph node dissection
- Prior ipsilateral axillary radiation
- Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an
axillary lymph node dissection in the surgeon's judgement
- Previous treatment for lymphedema of either arm or prescribed prophylactic treatment
for lymphedema.
- Pregnant patients cannot participate in the substudy
We found this trial at
2
sites
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: James Jakub, MD
Phone: 507-538-6984
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