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New surgery aims to drain chronic swelling in cancer survivors

NCT ID NCT06082349

Symptom relief Sponsor: Maastricht University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a surgery called lymphaticovenous anastomosis (LVA) to see if it reduces chronic swelling (lymphedema) in cancer survivors. About 110 people with swelling in one arm or leg after cancer treatment will be randomly assigned to receive either LVA or a sham surgery. The goal is to measure if LVA improves daily function and quality of life compared to a placebo procedure.

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 110 people

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

Started

Dec 2023

Expected to finish

Mar 2029

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: * Treated for cancer and underwent treatment of either axillary or inguinal lymph nodes or radiotherapy; * Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed by lymphoscintigraphy for the lower extremity; * Unilateral lymphedema; * Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stage II-III); * Refractory lymphedema that underwent at least three months of conservative treatment; * Informed consent. Exclusion Criteria: * History of lymphatic reconstruction in the past 10 years; * Late-stage lymphedema of the extremity (ISL classification ≥ II lymphedema) with evident fat deposition and/or fibrosis; * Patients with active distant metastases, treated with palliative intent; * Patients with the active treatment of primary cancer, i.e. surgery, radiotherapy, and/or chemotherapy. Note: patients receiving adjuvant targeted and/or endocrine treatment are eligible; * Edema due to venous insufficiency, evaluated by venous duplex ultrasound of the deep and superficial venous system; * Active infection in the lymphedematous extremity; * Bilateral lymphedema; * Lymphedema present in genital or breast area only; * Primary lymphedema; * Non-viable lymphatic system as determined by ICG Lymphography (stages IV and V).

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Conditions

The condition(s) this trial relates to.

lymphedema Neoplasm Metastasis

As listed by the trial registrant

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

Lymphedema arm Lymphedema of leg Lymphedema of upper limb Lymphedema, lower limb Lymphedema, secondary

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Erasmus University Medical Center

    RECRUITING

    Rotterdam, South Holland, 3015GD, Netherlands

  • Maastricht University Medical Center

    RECRUITING

    Maastricht, Limburg, 6229HX, Netherlands

  • Radboud University Medical Center

    RECRUITING

    Nijmegen, Gelderland, 6525GA, Netherlands

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