Nomogram to Predict Breast Cancer Related Lymphedema

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04665882
• Other study ID #: ZNJC201935
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2020
• Source: Wuhan University
• Contact: Qianqian Yuan, M.D.
• Phone: 13026322297
• Email: Yuanqq11[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Axillary Lymph Node Dissection
• Axillary Reverse Mapping
• Breast Cancer
• Breast Cancer Lymphedema
• Breast Cancer Related Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of arm lymphedema	A difference in volume between the arms < 10% was defined as lymphedema	Up to 5 years
Primary	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
Primary	Rate of distant metastasis	Cancer cells from breast metastasized to other organs.	Up to 5 years