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

Breast Cancer Lymphedema Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05120180
• Other study ID #: JTU-6H-20211011001
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Contact: FEN TANG, M.D., Ph.D.P
• Phone: +86(21)24058549
• Email: 690476877[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 261
• Est. completion date: March 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Procedure:
• axillary lymph node dissection with vein branches reservation
Spare the vein branches when ALND being performed
• axillary lymph node dissection without vein branches reservation
Don't spare the vein branches when ALND being performed

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xiangyun Zong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of lymphedema and dysfunction	Incidence of upper limb lymphedema and dysfunction on affected side after operation	5 year
Primary	Incidence of lymphedema	Incidence of upper limb lymphedema on affected side after operation	1 year
Primary	Incidence of dysfunction	Incidence of upper limb dysfunction on affected side after operation	1 year
Secondary	Incidence of lymphedema	Incidence of upper limb lymphedema on affected side after operation	1 month, 6 month
Secondary	Incidence of dysfunction	Incidence of upper limb dysfunction on affected side after operation	1 month, 6 month