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Axillary Reverse Mapping for Preventing Lymphedema in Breast Cancer
Study Summary
This trial looks at how well a surgery to preserve the lymph node drainage system around the breast works in preventing lymphedema after breast cancer surgery.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have received neoadjuvant chemotherapy but it has not been completed at least 2 weeks before registration.You are a woman.Your creatinine levels in the blood are not more than 1.5 times the upper limit of normal.Patients who have no signs of cancer in their lymph nodes and are having surgery to remove the breast and check the lymph nodes by a special test. If the lymph nodes are found to have cancer, additional surgery may be needed.You have been diagnosed with cancer in the lymph nodes and are planning to have a specific type of surgery for breast cancer.Patients with specific tumor sizes undergoing surgery on their armpit area.You are able to perform daily activities without any issues or with only slight limitations due to your health.You have not had breast cancer on the same side as the current one, but non-invasive conditions or benign diseases are allowed. If you received chemotherapy before, it must have been finished at least 2 weeks before joining the study.You have never had swelling in either of your arms due to lymphedema.You do not have invasive breast cancer in both breasts.Your lymph nodes are not clumped together.Patients will be evaluated and classified based on the TNM staging system.
- Group 1: Group I (ALND)
- Group 2: Group II (ARM, ALND)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
In which areas is this research being conducted?
"Currently, there are 86 sites actively recruiting for this study. Some of these locations include the University of Pennsylvania/Abramson Cancer Center in Philadelphia, UM Sylvester Comprehensive Cancer Center at Plantation in Plantation, and UH Seidman Cancer Center at Saint John Medical Center in Westlake."
What is the standard purpose of Axillary Lymph Node Dissection?
"chylous ascites often requires treatment through Axillary Lymph Node Dissection. This procedure can also help patients struggling with limb structure, lymphangiograph, and chylothorax."
Are there any other ongoing research projects similar to this one involving Axillary Lymph Node Dissection?
"University of Oklahoma Health Sciences Center first published data on Axillary Lymph Node Dissection in 2019. Since that time, there have been 237 completed clinical trials and 1 active study. The latter is recruiting patients in Philadelphia, Pennsylvania."
How many people have expressed interest in this experiment?
"This study is no longer recruiting patients. The date the study was first posted was May 31st, 2019, and the date of the most recent edit was March 22nd, 2022. There are other trials that may be of interest; there are 2400 studies recruiting patients with lymphedema and 1 Axillary Lymph Node Dissection trial that is currently enrolling participants."
Has the FDA cleared Axillary Lymph Node Dissection for medical use?
"There is some data to support the efficacy of Axillary Lymph Node Dissection, and multiple rounds of data have been collected to support its safety. As such, our team has given it a score of 3."
Are there any volunteer opportunities available for this research?
"Currently, this clinical trial is not recruiting patients. The study was posted on May 31st, 2019 and was last updated on March 22nd, 2022. If you are interested in other clinical trials, there are currently 2400 trials actively admitting participants with lymphedema and 1 trial for Axillary Lymph Node Dissection actively admitting patients."
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