Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2020-12-11
2027-12-31
Brief Summary
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This arm lymphedema prediction model that included the protective factor, the proportion of arm lymph flow above the level of axillary vein, allows intraoperative intervention to be performed for the high-risk group. The arm lymphatics of these distinguished patients would be preserved to eliminate the occurrence of arm lymphedema in this study.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Axillary surgery based on lymphedema prediction nomogram
Based on the intraoperative lymphedema prediction nomogram, individualized treatment was recommended to breast cancer patients with different level of risk. For patients with low possibility of developing breast cancer related lymphedema, it was not necessary to preserve arm lymphatics. While the breast cancer patients who were performed mastectomy and ALND with 28 kg/m2 prepared to receive taxane-based chemotherapy, supraclavicular and infraclavicular radiotherapy, according to the established intraoperative nomogram, the proportion of the arm lymph flow above the axillary vein needed to exceed 52%. Otherwise, the arm lymphatics should be identified and preserved.
Axillary surgery based on lymphedema prediction nomogram
Based on the intraoperative lymphedema prediction nomogram, individualized treatment was recommended to breast cancer patients with different level of risk. For patients with low possibility of developing breast cancer related lymphedema, it was not necessary to preserve arm lymphatics. While the breast cancer patients who were performed mastectomy and ALND with 28 kg/m2 prepared to receive taxane-based chemotherapy, supraclavicular and infraclavicular radiotherapy, according to the established intraoperative nomogram, the proportion of the arm lymph flow above the axillary vein needed to exceed 52%. Otherwise, the arm lymphatics should be identified and preserved.
Standard axillary lymph node dissection
Standard axillary lymph node dissection was performed with complete resection of Berg's levels I and II.
No interventions assigned to this group
Interventions
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Axillary surgery based on lymphedema prediction nomogram
Based on the intraoperative lymphedema prediction nomogram, individualized treatment was recommended to breast cancer patients with different level of risk. For patients with low possibility of developing breast cancer related lymphedema, it was not necessary to preserve arm lymphatics. While the breast cancer patients who were performed mastectomy and ALND with 28 kg/m2 prepared to receive taxane-based chemotherapy, supraclavicular and infraclavicular radiotherapy, according to the established intraoperative nomogram, the proportion of the arm lymph flow above the axillary vein needed to exceed 52%. Otherwise, the arm lymphatics should be identified and preserved.
Eligibility Criteria
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Inclusion Criteria
* Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast;
* Patients who underwent mastectomy with a positive sentinel lymph node (SLN);
* Patients who underwent breast-conserving surgery containing more than two positive SLNs.
Exclusion Criteria
* Previous history of breast cancer.
18 Years
80 Years
FEMALE
No
Sponsors
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Wuhan University
OTHER
Responsible Party
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Gaosong Wu, Ph D, MD
Director
Principal Investigators
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Gaosong Wu, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Wuhan University
Locations
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Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Qianqian Yuan, MD.
Role: primary
Other Identifiers
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ZNJC201935
Identifier Type: -
Identifier Source: org_study_id