Clinical trial NCT05246592: Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer
Official title: Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision Differs Due to the Ratio of Axillary Lymphatic and Axillary Vein Reflux in Breast Cancer Patients: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer Lymphedema
Keywords: Breast Cancer
Axillary Lymph Node Dissection
Post-mastectomy Lymphedema
Upper Limb Dysfunction
axillary lymphatic reflux
axillary vein reflux
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients recruited in the PLEDGE study （NCT05120180）

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).


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 (0-1),
* 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.

Primary outcomes:
measure: short-term Incidence of lymphedema
timeFrame: 1-, 6-, and 12-month
measure: short-term Incidence of dysfunction
timeFrame: 1-, 6-, and 12-month
Secondary outcomes:
measure: long-term Incidence of lymphedema
timeFrame: 5 years
measure: long-term Incidence of dysfunction
timeFrame: 5 years
Other outcomes:
measure: Risk model
timeFrame: 5 years
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai Fengxian Central Hospital
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: XIANGYUN ZONG, MD, PhD
role: STUDY_CHAIR
References: