Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer

Recruiting

• Conditions: Breast Cancer Lymphedema

• Registration Number: NCT05246592
• Lead Sponsor: Xiangyun Zong

Brief Summary

The purpose of this study is to compare the difference in the incidence of upper limb edema and dysfunction between the Preponderant lymphatic reflux group (high ratio of axillary lymphatic reflux to axillary vein reflux) and the Preponderant venous reflux group (low ratio of axillary lymphatic reflux to axillary vein reflux).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-03
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

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 (0-1),
• 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
short-term Incidence of lymphedema	1-, 6-, and 12-month	Incidence of upper limb lymphedema on affected side at 1-, 6-, and 12-month after operation
short-term Incidence of dysfunction	1-, 6-, and 12-month	Incidence of upper limb dysfunction on affected side at 1-, 6-, and 12-month after operation

Secondary Outcome Measures

Name	Time	Method
long-term Incidence of lymphedema	5 years	Incidence of upper limb lymphedema on affected side 5 years after operation
long-term Incidence of dysfunction	5 years	Incidence of upper limb dysfunction on affected side 5 years after operation

Trial Locations

Locations (3)

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai Fengxian Central Hospital; 🇨🇳 Shanghai, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China