Nomogram to Predict Breast Cancer Related Lymphedema

Study Overview
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Brief Summary
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It has been hypothesized that damaged arm lymphatic drainage is associated with the arm lymphedema after axillary lymph node dissection (ALND). However, the majority of breast cancer patients with complete ALND has not suffered from arm lymphedema, which appears to be due to the residual arm lymph nodes that has not been removed in the axillary dissection. With the compensation of the residual arm lymph flow above the level of axillary vein, the arm lymphatic drainage could keep balance and remain normal function. 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.

Official Title
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Intraoperative Nomogram to Predict Breast Cancer- Related Lymphedema Based in Artificial Intelligence Image Recognition: a Randomized Controlled Trial

Conditions
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Breast Cancer, Axillary Lymph Node Dissection, Breast Cancer Related Lymphedema, Axillary Reverse Mapping

Intervention / Treatment
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* Procedure: Axillary surgery based on lymphedema prediction nomogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or older with T1-3 invasive breast cancer; 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: Neoadjuvant chemotherapy; Previous history of breast cancer.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Axillary surgery based on lymphedema prediction nomogram<br>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. | Procedure: Axillary surgery based on lymphedema prediction nomogram<br>* 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.<br>|
| No Intervention: Standard axillary lymph node dissection<br>Standard axillary lymph node dissection was performed with complete resection of Berg's levels I and II. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of arm lymphedema | A difference in volume between the arms < 10% was defined as lymphedema | Up to 5 years | 
| Rate of locoregional recurrence | Locoregional recurrence included local recurrence and regional recurrence. Local recurrence was defined as chest wall recurrence of breast cancer, and regional recurrence was defined as the axilla recurrence of breast cancer | Up to 5 years | 
| Rate of distant metastasis | Cancer cells from breast metastasized to other organs. | Up to 5 years |