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The researchers are doing this study to see if having immediate lymphatic reconstruction after axillary lymph node dissection (ALND) can decrease the development of lymphedema, a side effect of ALND. Other purposes of the study include:
Comparing the approach of immediate lymphatic reconstruction after ALND with the approach of ALND alone Looking at whether having immediate lymphatic reconstruction after ALND improves a person's quality of life Seeing if adding standard of care radiation therapy to either study approach (immediate lymphatic reconstruction after ALND or ALND alone) has an effect on development of lymphedema
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| axillary lymph node dissection with ILR | Experimental |
| |
| axillary lymph node dissection (ALND) without ILR | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction | Procedure | Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| the number of patients that had a decrease incidence of lymphedema | as measured by arm volume will be a ≥10% increase in arm volume | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Breast Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Coriddi, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent and Followup) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Patients will be randomized to one of two groups:
ALND with ILR (intervention group) and ALND without ILR (control group; current standard treatment at Memorial Sloan Kettering [MSK]).
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| Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction | Procedure | Current standard treatment at Memorial Sloan Kettering [MSK]). |
|
| quality-of-life questionnaires | Other | Four validated patient reported outcome measures (PROMs): the Upper Limb Lymphedema-27 (ULL-27), the Quality of Life Measure for Limb Lymphedema (LYMQOL), the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Anxiety Inventory (BAI). Study participants will undergo standard lymphedema measurements and quality-of-life questionnaires at baseline before ALND and postoperatively at 6 weeks (+/- 30 days) and at 6, 12, 18, and 24 months (+/- 30 days). If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them. |
|
| measured by arm volume | Other | Bilateral arm volumes will be measured with sequential circumferential measurements with the truncated cone formula. If a patient cannot return to Manhattan for these assessments but is seen by a lymphedema therapist in a regional location or at an institution outside of MSK as part of their routine cancer treatment, this data can be used in the final analysis |
|
| Memorial Sloan Kettering Monmouth (Consent Only) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen (Consent Only) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (Consent only) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Consent Only) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau (Consent only) | Uniondale | New York | 11553 | United States |
| ID | Term |
|---|---|
| D000072656 | Breast Cancer Lymphedema |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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