Back to results

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

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

NCT ID

NCT05120180

First Posted

October 25, 2021

Last Updated

January 24, 2023

Sponsor

Xiangyun Zong

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs