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

Primary Purpose

Breast Cancer Lymphedema

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
axillary lymph node dissection with vein branches reservation
axillary lymph node dissection without vein branches reservation
Sponsored by
Xiangyun Zong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Lymphedema focused on measuring Breast Cancer, Axillary Lymph Node Dissection, Post-mastectomy Lymphedema, Upper Limb Dysfunction, Axillary Vein Branches Reservation

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Jiao Tong University Affiliated Sixth People's HospitalRecruiting
  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Branches Sparing

None Branches Sparing

Arm Description

The patients in this arm will undergo axillary lymph node dissection with preserved axillary vein branches

The patients in this arm will undergo axillary lymph node dissection without preserved axillary vein branches

Outcomes

Primary Outcome Measures

Incidence of lymphedema
Incidence of upper limb lymphedema on affected side after operation
Incidence of dysfunction
Incidence of upper limb dysfunction on affected side after operation

Secondary Outcome Measures

Incidence of lymphedema
Incidence of upper limb lymphedema on affected side after operation
Incidence of dysfunction
Incidence of upper limb dysfunction on affected side after operation

Full Information

First Posted
October 25, 2021
Last Updated
January 24, 2023
Sponsor
Xiangyun Zong
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1. Study Identification

Unique Protocol Identification Number
NCT05120180
Brief Title
Effect of ALND With Vein Branches Reservation on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer
Acronym
PLEDGE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiangyun Zong

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Lymphedema
Keywords
Breast Cancer, Axillary Lymph Node Dissection, Post-mastectomy Lymphedema, Upper Limb Dysfunction, Axillary Vein Branches Reservation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Branches Sparing
Arm Type
Experimental
Arm Description
The patients in this arm will undergo axillary lymph node dissection with preserved axillary vein branches
Arm Title
None Branches Sparing
Arm Type
Active Comparator
Arm Description
The patients in this arm will undergo axillary lymph node dissection without preserved axillary vein branches
Intervention Type
Procedure
Intervention Name(s)
axillary lymph node dissection with vein branches reservation
Intervention Description
Spare the vein branches when ALND being performed
Intervention Type
Procedure
Intervention Name(s)
axillary lymph node dissection without vein branches reservation
Intervention Description
Don't spare the vein branches when ALND being performed
Primary Outcome Measure Information:
Title
Incidence of lymphedema
Description
Incidence of upper limb lymphedema on affected side after operation
Time Frame
1 year
Title
Incidence of dysfunction
Description
Incidence of upper limb dysfunction on affected side after operation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of lymphedema
Description
Incidence of upper limb lymphedema on affected side after operation
Time Frame
1 month, 6 month
Title
Incidence of dysfunction
Description
Incidence of upper limb dysfunction on affected side after operation
Time Frame
1 month, 6 month
Other Pre-specified Outcome Measures:
Title
Incidence of lymphedema and dysfunction
Description
Incidence of upper limb lymphedema and dysfunction on affected side after operation
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FEN TANG, M.D., Ph.D.P
Phone
+86(21)24058549
Email
690476877@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XIANGYUN ZONG, M.D., Ph.D.P
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FEN TANG, MD
Phone
+86(21)24058549
Email
690476877@qq.com
First Name & Middle Initial & Last Name & Degree
XIANGYUN ZONG, MD, PHD
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YANG YU, M.D.
Phone
+86(21)88122222
Email
yuyangkaiyu@163.com
First Name & Middle Initial & Last Name & Degree
HONGJIAN YANG, M.D.
First Name & Middle Initial & Last Name & Degree
YANG YU, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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