Nomogram to Predict Breast Cancer Related Lymphedema

Wuhan University

Status: Enrolling

Conditions: Breast Cancer; Breast Cancer Related Lymphedema; Axillary Lymph Node Dissection; Axillary Reverse Mapping

Treatments: Procedure: Axillary surgery based on lymphedema prediction nomogram

Study type: Interventional

Funder types: Other

Identifiers

NCT04665882

ZNJC201935

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Axillary surgery based on lymphedema prediction nomogram

Experimental group

Description:

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.

Treatment:

Procedure: Axillary surgery based on lymphedema prediction nomogram

Standard axillary lymph node dissection

No Intervention group

Description:

Standard axillary lymph node dissection was performed with complete resection of Berg's levels I and II.