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Nomogram to Predict Breast Cancer Related Lymphedema

Primary Purpose

Breast Cancer, Axillary Lymph Node Dissection, Breast Cancer Related Lymphedema

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Axillary surgery based on lymphedema prediction nomogram
Sponsored by
Wuhan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Zhongnan Hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Axillary surgery based on lymphedema prediction nomogram

Standard axillary lymph node dissection

Arm 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.

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

Outcomes

Primary Outcome Measures

Rate of arm lymphedema
A difference in volume between the arms < 10% was defined as lymphedema
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
Rate of distant metastasis
Cancer cells from breast metastasized to other organs.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2020
Last Updated
December 11, 2020
Sponsor
Wuhan University
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1. Study Identification

Unique Protocol Identification Number
NCT04665882
Brief Title
Nomogram to Predict Breast Cancer Related Lymphedema
Official Title
Intraoperative Nomogram to Predict Breast Cancer- Related Lymphedema Based in Artificial Intelligence Image Recognition: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Axillary Lymph Node Dissection, Breast Cancer Related Lymphedema, Axillary Reverse Mapping

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Axillary surgery based on lymphedema prediction nomogram
Arm Type
Experimental
Arm 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.
Arm Title
Standard axillary lymph node dissection
Arm Type
No Intervention
Arm Description
Standard axillary lymph node dissection was performed with complete resection of Berg's levels I and II.
Intervention Type
Procedure
Intervention Name(s)
Axillary surgery based on lymphedema prediction nomogram
Intervention 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.
Primary Outcome Measure Information:
Title
Rate of arm lymphedema
Description
A difference in volume between the arms < 10% was defined as lymphedema
Time Frame
Up to 5 years
Title
Rate of locoregional recurrence
Description
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
Time Frame
Up to 5 years
Title
Rate of distant metastasis
Description
Cancer cells from breast metastasized to other organs.
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qianqian Yuan, M.D.
Phone
13026322297
Email
Yuanqq11@whu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaosong Wu, Ph.D.
Organizational Affiliation
Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qianqian Yuan, MD.
Phone
+8613026322297
Email
Yuanqq11@whu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Nomogram to Predict Breast Cancer Related Lymphedema

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