Effect of ALND With Vein Branches Reservation on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer (PLEDGE)

January 23, 2024 updated by: Xiangyun Zong

Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision With or Without Axillary Vein Branches Reservation in Breast Cancer Patients: a Prospective, Multiple-center, Double-blinded, Randomized Controlled Study

The purpose of this study is to compare the effects of axillary lymph node dissection with or without axillary vein branches reservation on the affected upper limb edema and dysfunction in breast cancer patients, and to explore the solutions to prevent the affected upper limb edema and dysfunction after ALND.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: FEN TANG, M.D., Ph.D.P
  • Phone Number: +86(21)24058549
  • Email: 690476877@qq.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200233
        • Recruiting
        • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
        • Contact:
        • Principal Investigator:
          • XIANGYUN ZONG, MD, PHD
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • HONGJIAN YANG, M.D.
        • Sub-Investigator:
          • YANG YU, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-69 years old,
  • Regardless of gender,
  • Breast masses were diagnosed by histology and pathology, stage II -III.
  • Clinical palpation of axillary lymph nodes is positive, or
  • Axillary lymph node puncture pathology is positive, or
  • The multidisciplinary treatment cooperation group (MDT) recommends axillary lymph node dissection,
  • Good physical state score (0-2),
  • No severe organ complications,
  • No congenital or acquired diseases affecting the normal morphology and functional activities of the upper limbs,
  • Informed consent, understanding and compliance with research requirements.

Exclusion Criteria:

  • Pregnancy or lactation,
  • Inflammatory breast cancer,
  • Clinical findings of metastatic lesions,
  • Sentinel lymph node biopsy was negative,
  • History of upper limb or shoulder, chest, back trauma or surgery,
  • Previous history of local radiotherapy,
  • History of other tumors,
  • Vascular embolic disease,
  • Those who are unable to comply with the clinical trial requirements for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Branches Sparing
The patients in this arm will undergo axillary lymph node dissection with preserved axillary vein branches
Procedure: axillary lymph node dissection with vein branches reservation
Spare the vein branches when ALND being performed
Active Comparator: None Branches Sparing
The patients in this arm will undergo axillary lymph node dissection without preserved axillary vein branches
Procedure: axillary lymph node dissection without vein branches reservation
Don't spare the vein branches when ALND being performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of lymphedema
Time Frame: 1 year
Incidence of upper limb lymphedema on affected side after operation
1 year
Incidence of dysfunction
Time Frame: 1 year
Incidence of upper limb dysfunction on affected side after operation
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of lymphedema
Time Frame: 1 month, 6 month
Incidence of upper limb lymphedema on affected side after operation
1 month, 6 month
Incidence of dysfunction
Time Frame: 1 month, 6 month
Incidence of upper limb dysfunction on affected side after operation
1 month, 6 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of lymphedema and dysfunction
Time Frame: 5 year
Incidence of upper limb lymphedema and dysfunction on affected side after operation
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangyun Zong

Investigators

  • Study Chair: XIANGYUN ZONG, M.D., Ph.D.P, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2022

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JTU-6H-20211011001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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