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New surgical trick could stop arm swelling in breast cancer survivors

NCT ID NCT07415200

Prevention Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a surgical technique done at the same time as breast cancer lymph node removal to prevent arm lymphedema (chronic swelling). The procedure uses a small flap of tissue from the side of the chest to rebuild the armpit area and support fluid drainage. One hundred high-risk women will be followed for two years to see if the technique safely reduces swelling.

What this could mean

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

Active substance
Pedicled lateral chest wall lymph-adipofascial flap axillary reconstruction (a surgical procedure)
What this could lead to
If successful, this simple surgical technique could become a standard way to prevent chronic arm swelling in high-risk breast cancer patients, improving their quality of life.
What could go wrong
This is a small, early-phase study with no comparison group, so results may not be definitive. The surgery itself carries risks like infection or flap failure, and it may not prevent lymphedema in all patients.

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.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

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: 1. Female patients aged 18 to 75 years; 2. Histologically confirmed invasive breast cancer; 3. Pathologically confirmed axillary lymph node metastasis requiring axillary lymph node dissection; 4. Body mass index (BMI) ≥ 25 kg/m²; 5. Planned to receive postoperative regional lymph node radiation therapy; 6. Ability to understand the study procedures and provide written informed consent; 7. Willingness and ability to comply with study follow-up and assessments. Exclusion Criteria: 1. Previous surgery involving the ipsilateral axilla; 2. Previous radiation therapy to the ipsilateral axilla; 3. Evidence of distant metastatic breast cancer; 4. Bilateral breast cancer, or a history of contralateral breast cancer surgery; 5. Severe hepatic or renal dysfunction, or severe cardiac insufficiency; 6. Inability to read or understand Chinese sufficiently to complete study questionnaires and assessments; 7. Pregnancy; 8. Any condition or circumstance that, in the investigator's judgment, may interfere with study compliance or follow-up.

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Conditions

The condition(s) this trial relates to.

breast cancer Breast Cancer Lymphedema breast neoplasm invasive breast carcinoma Postoperative Complications

As listed by the trial registrant

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

Breast cancer Breast cancer-related lymphedema Postoperative complications

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

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Contacts and locations

Locations

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000, China

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