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Simple survey could catch arm swelling early in breast cancer patients

NCT ID NCT05929001

Knowledge-focused Sponsor: University of Miami 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether focused questionnaires can detect lymphedema—a common complication after armpit lymph node removal—earlier than physical measurements like arm circumference. Researchers followed 101 breast cancer patients who had or were scheduled for axillary dissection. They compared patient-reported outcomes from several quality-of-life surveys with standard physical tests to see if the surveys could identify lymphedema sooner.

What this could mean

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

What this could lead to
If successful, this could lead to a simple, non-invasive way to catch lymphedema early, improving treatment options for breast cancer patients.
What could go wrong
This is a small, completed study focused on measurement tools, not a treatment. The questionnaires may not be accurate enough to replace physical exams.

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.

Participants

101 people

The number who actually took part.

Started

Jan 2021

Finished

Apr 2026

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.

Who is studied

Breast cancer patients who are scheduled for or who just had axillary dissection at the University of Miami.

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 18 years old and older with biopsy-proven breast cancer. * Scheduled for axillary dissection or probable axillary dissection or within 14 days after axillary dissection at either Jackson Memorial Hospital (JMH) or University of Miami (UM). * Patients that eventually did not undergo full axillary dissection but had 9 or more lymph nodes removed or received axillary radiation will be allowed to stay in the study. * Intent to continue follow-up for at least 6 months post-operatively. * Able to give an informed consent to participate in all study's stages. * Willing and able to fill questionnaires in person or with assistance at baseline and at 6 months from surgery. * Bilateral axillary dissection patients are eligible to be enrolled for each side. Exclusion Criteria: * Previous axillary dissection. * Lymph node biopsy except for biopsies related to the current cancer event. * Congenital or acquired arm lymphedema. * Nephrotic Syndrome * Anasarca * Unable or unwilling to fill questionnaires at baseline and at 6 months from surgery.

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Conditions

The condition(s) this trial relates to.

breast cancer lymphedema

As listed by the trial registrant

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

Lymphedema

Contacts and locations

Locations

  • University of Miami

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.