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

NCT05120180 | Active Not Recruiting DMC

• 1 other identifier: JTU-6H-20211011001
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer Lymphedema

Keywords

Breast Cancer; Axillary Lymph Node Dissection; Post-mastectomy Lymphedema; Upper Limb Dysfunction; Axillary Vein Branches Reservation

Outcome Measures

Primary Outcomes (2)

• short-term Incidence of lymphedema

  short-term Incidence of upper limb lymphedema on affected side after operation

  1-, 6-, and 12-month

• short-term Incidence of dysfunction

  short-term Incidence of upper limb dysfunction on affected side after operation

  1-, 6-, and 12-month

Secondary Outcomes (2)

• long-term Incidence of lymphedema

  5 yearsye

• long-term Incidence of dysfunction

  5 years

Other Outcomes (1)

• TFS

  5 years

Study Arms (2)

Branches Sparing

EXPERIMENTAL

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

None Branches Sparing

ACTIVE COMPARATOR

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

Interventions

axillary lymph node dissection with vein branches reservation PROCEDURE

Spare the vein branches when ALND being performed

Branches Sparing

axillary lymph node dissection without vein branches reservation PROCEDURE

Don't spare the vein branches when ALND being performed

None Branches Sparing

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangyun Zong: lead

Study Sites (3)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Shanghai Fengxian Central Hospital

Shanghai, 201499, China

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• XIANGYUN ZONG, M.D., Ph.D.P

  Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Breast Cancer, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 15, 2021
• Study Start: January 3, 2022
• Primary Completion: April 1, 2024
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)