Nomogram to Predict Breast Cancer Related Lymphedema

Not Applicable

Recruiting

• Conditions: Axillary Reverse Mapping; Breast Cancer; Breast Cancer Related Lymphedema; Axillary Lymph Node Dissection
• Interventions: Procedure: Axillary surgery based on lymphedema prediction nomogram

• Registration Number: NCT04665882
• Lead Sponsor: Wuhan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Study Start: 2020-12-11
• Last Update Submitted: 2020-12-11
• Study First Posted: 2020-12-14
• Last Update Posted: 2020-12-16
• Primary Completion: 2022-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Axillary surgery based on lymphedema prediction nomogram	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.

Primary Outcome Measures

Name	Time	Method
Rate of distant metastasis	Up to 5 years	Cancer cells from breast metastasized to other organs.
Rate of arm lymphedema	Up to 5 years	A difference in volume between the arms \< 10% was defined as lymphedema
Rate of locoregional recurrence	Up to 5 years	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

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China