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New surgical trick may stop arm swelling in breast cancer patients

NCT ID NCT07515300

Prevention Sponsor: Hospital Universitari de Bellvitge 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special surgical technique called Axillary Reverse Mapping (ARM) can prevent lymphedema (arm swelling) in breast cancer patients who need lymph node removal. The ARM technique aims to preserve the arm's lymph drainage during surgery. 100 patients will be randomly assigned to receive either standard surgery or surgery with the ARM technique, and their arm swelling rates will be compared.

What this could mean

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

Active substance
Axillary Reverse Mapping (ARM) technique
What this could lead to
If successful, this could offer a simple surgical method to prevent chronic arm swelling after breast cancer surgery, improving quality of life.
What could go wrong
This is a small, early-stage trial with only 100 participants, so results may not apply to all patients. The technique may not reduce lymphedema or could have unforeseen risks.

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 100 people

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

Started

Mar 2026

Expected to finish

Apr 2028

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: Breast cancer patients with an indication for axillary lymphadenectomy according to the multidisciplinary team: * cN0 with positive sentinel lymph node biopsy (pN+) requiring axillary lymphadenectomy: cT3; More than two axillary macrometastases; or patients undergoing mastectomy without indication for adjuvant radiotherapy * cN1: Primary surgery; or after neoadjuvant therapy without complete axillary response and/or positive TAD (ypN+) * cN2: Primary surgery; or after neoadjuvant therapy in luminal tumors and/or without complete axillary response in triple-negative or HER2-positive tumors, and/or positive TAD (ypN+) Exclusion Criteria: * Patients with prior axillary radiotherapy * Patients with suspected metastatic involvement based on palpation of ARM lymph nodes during the surgical procedure * Patients participating in other studies whose primary objective depends on local axillary treatment * Patients unwilling to participate in the study

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm lymphedema prevention target

As listed by the trial registrant

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

Breast cancer Lymphedema arm

Contacts and locations

Locations

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

More trials for these conditions

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