A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection (NCT01969253) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection
South Korea400 participantsStarted 2012-05
Plain-language summary
Over the past few years, several studies have been made on various outcomes about the incidence of lymphedema. Because the outcomes can be came out differently each study by measurement, criteria, treatment period, treatment method and morbid extremities of lymphedema. Therefore it is required for understanding about the incidence, risk factor and physical progress for to be treated and prevented of lymphedema. Also it is necessary that to understand characteristics of lymphedema measurements and to establish diagnostic criteria of lymphedema through comparative study.
The aim of this study was to analyze the incidence and risk factor of lymphedema through prospectively observation, and to determine effects on the quality of life of lymphedema after breast cancer surgery with ALND.
Who can participate
Age range
20 Years
Sex
FEMALE
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:
* Older than 20 years old
* Patient who underwent unilateral Breast Cancer surgery with ALND
* Informed consent must to be signed
Exclusion Criteria:
* Previous history of breast cancer
* History of abnormality or vascular disease in upper extremity
* Patients with other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
* History of infection on upper extremity
* History of corticosteroid use on whole body for any reason
* Inability to provide informed consent (e.g. dementia or severe cognitive impairment)
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
1
To evaluate the incidence of lymphedema in upper arm after ALND