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New surgery aims to stop lymphedema before it starts

NCT ID NCT03941756

Prevention Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a procedure called lymphovenous bypass, done before underarm lymph node removal, can prevent lymphedema (arm swelling) in patients with breast cancer or melanoma. About 252 participants will receive the bypass during their cancer surgery. Researchers will then monitor arm volume changes over time to see if the procedure lowers the chance of developing lymphedema compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lymphovenous bypass procedure
What this could lead to
If successful, this procedure could become a standard preventive step during lymph node surgery, reducing the risk of chronic arm swelling for many cancer patients.
What could go wrong
This is an early pilot study with no control group, so results may not prove effectiveness. The procedure itself carries surgical risks like infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 252 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients greater than or equal to 18 years of age. * Patients willing to participate. * Patients able to complete informed consent. * Patients will be eligible for inclusion if they fall into one for two groups: * Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy * Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group. Exclusion Criteria: * Patients taking anticoagulants within 7 days prior to surgery. * Patients that are known to be pregnant at the time of surgery. * Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period. * Patients with body mass index (BMI) greater than 50.0.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma inflammatory breast carcinoma invasive breast carcinoma melanoma lymphedema prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anatomic stage III breast cancer ajcc V8 Breast inflammatory carcinoma Locally advanced breast carcinoma Melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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