Active — Not RecruitingNot Applicable

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

China258 participantsStarted 2022-01-03

Plain-language 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.

Who can participate

Age range

18 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

short-term Incidence of lymphedema

Timeframe: 1-, 6-, and 12-month

short-term Incidence of dysfunction

Timeframe: 1-, 6-, and 12-month

Trial details

NCT IDNCT05120180

SponsorXiangyun Zong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-01

View on ClinicalTrials.gov More Breast Cancer Lymphedema trials