TerminatedNot Applicable

Preventing Lymphedema in Axillary Lymph Node Dissection

Stopped: slow accrual; diminished funding

United States264 participantsStarted 2018-04-10

Plain-language summary

The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.

Who can participate

Age range

18 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 * Patients scheduled to undergo an axillary lymph node dissection * Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings * English speaking Exclusion Criteria * Prior ipsilateral axillary lymph node dissection * Prior ipsilateral axillary radiation * Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement * Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema. * Pregnant patients cannot participate in the substudy

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

Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity

Timeframe: 36 months following surgery

Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity

Timeframe: 36 months following surgery

Trial details

NCT IDNCT03428581

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-11

View on ClinicalTrials.gov More Lymphedema trials