Nomogram to Predict Breast Cancer Related Lymphedema

NCT04665882 | Recruiting DMC

• 1 other identifier: ZNJC201935
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Axillary surgery based on lymphedema prediction nomogram

EXPERIMENTAL

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

Standard axillary lymph node dissection

NO INTERVENTION

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

Interventions

Axillary surgery based on lymphedema prediction nomogram PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Neoadjuvant chemotherapy;
• Previous history of breast cancer.

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaosong Wu, Ph.D.

  Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qianqian Yuan, M.D.

CONTACT

13026322297; Yuanqq11@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: December 11, 2020
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

CN (1)