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New study tests simple strategy to stop breast cancer arm swelling for good

NCT ID NCT04522648

Disease control Sponsor: Rigshospitalet, Denmark 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 closely monitoring arm swelling after breast cancer surgery and treating it early with a compression sleeve can prevent long-term lymphedema. 250 women who had many lymph nodes removed will be randomly assigned to either the monitoring program or usual care. The goal is to see if early treatment reduces the number of women who develop chronic arm swelling.

What this could mean

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

Active substance
prospective surveillance program with compression garment
What this could lead to
If successful, this approach could reduce the number of women who develop long-term arm swelling after breast cancer surgery.
What could go wrong
This is a relatively small trial in one country, and the benefit may not apply to all patients. The intervention only manages symptoms, not the underlying cause.

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 250 people

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

Started

Jan 2021

Expected to finish

Dec 2026

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: * female; * ≥18 years; * surgery for breast cancer (unilateral and bilateral) including ALDN with \>6 lymph nodes removed; * can effectively communicate verbally in Danish; Exclusion Criteria: * surgery for breast cancer with SLNB or \< 6 nodes removed; * pre-existing lymphedema (primary or secondary); * previous treatment for breast cancer; * pace maker; * conditions known to cause swelling (pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis or deep vein thrombosis in the arms).

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm lymphedema

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Copenhagen University Hospital Rigshospitalet

    Copenhagen, 2100, Denmark

  • Herlev Hospital

    Herlev, Denmark

  • Odense University Hospital

    Odense, Denmark

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