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New surgery aims to stop lymphedema before it starts

NCT ID NCT04241341

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a surgical technique called immediate lymphatic reconstruction can prevent lymphedema (arm swelling) in breast cancer patients who need lymph node removal. About 180 women will be randomly assigned to receive either standard lymph node removal alone or with the additional reconstruction. The goal is to see if the extra procedure reduces the chance of developing lymphedema and improves quality of life.

What this could mean

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

Active substance
Immediate lymphatic reconstruction (surgical procedure)
What this could lead to
If it works, this could offer a way to prevent chronic arm swelling after breast cancer surgery, improving quality of life.
What could go wrong
This is a single-center trial with 180 patients, so results may not apply to everyone. The procedure requires finding suitable lymphatic channels during surgery, which isn't always possible.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

180 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Jan 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 to 75 years

Sex

Female participants only

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: * Female breast cancer patients 18-75 years of age * Patients consenting for unilateral ALND (prior history of SLNBx allowed if \<6 months from consent) OR patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon * Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery Exclusion Criteria: * Male breast cancer patients * Non-English speaking participants * Female breast cancer patients with axillary recurrence * Female breast cancer patients who have a history of ALND * Female patients requiring bilateral ALND for the treatment of their breast cancer * Female breast patients treated with SLNBx only

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Conditions

The condition(s) this trial relates to.

breast cancer Breast Cancer Lymphedema lymphedema prevention target

As listed by the trial registrant

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

Breast cancer lymphedema

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (Consent and Followup)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Consent Only)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (Consent only)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Consent Only)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Consent only)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Consent Only)

    Harrison, New York, 10604, United States

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