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Blood marker may predict chemo nerve damage risk

NCT ID NCT06430814

Knowledge-focused Sponsor: University of Southern Denmark Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is looking for a way to predict which breast cancer patients will develop nerve damage (peripheral neuropathy) from the chemotherapy drug paclitaxel. Researchers will measure a protein called NFL in the blood after the first round of chemo to see if high levels can identify patients who may need to stop treatment early. The goal is to find a simple blood test that helps doctors personalize chemotherapy and reduce side effects.

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 help doctors identify patients at high risk for nerve damage before starting paclitaxel, allowing for personalized treatment plans.
What could go wrong
This is an observational study, not a treatment trial. The biomarker being tested may not reliably predict neuropathy 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.

Participants

About 188 people

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

Started

Oct 2024

Expected to finish

Sep 2027

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.

Who is studied

A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across four trial sites.

Ages

18 years and older

Sex

Female participants only

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: * Age \> 18 years * Willing to give informed consent * Scheduled to receive neo-adjuvant or adjuvant paclitaxel treatment * Able to speak and understand Danish * Diagnosed with breast cancer * Paclitaxel naïve patients Exclusion Criteria: * Neurodegenerative diseases (e.g., neuropathy from another cause, previous apoplexy, disc herniation * Type 1 or 2 diabetes * Pregnant * Breastfeeding * Relapse of cancer diagnosis * Diagnosed with human immunodeficiency virus (HIV) * Participation in other clinical trials where the dose of paclitaxel is changed, or the aim is to prevent neuropathic pain or decrease NFL level (except if the intervention is to use cooling gloves). * Previous treatment with neurotoxic chemotherapy * Chronic pain from another cause * Metastatic cancer

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Conditions

The condition(s) this trial relates to.

breast cancer chemotherapy-induced neuropathy

As listed by the trial registrant

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

Chemotherapy-induced peripheral neuropathy

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

  • Odense University Hospital

    RECRUITING

    Odense, 5000, Denmark

  • University Hospital of Southern Denmark, Sønderborg

    RECRUITING

    Sønderborg, 6400, Denmark

  • University Hospital of Southern Denmark, Vejle

    RECRUITING

    Vejle, 7100, Denmark

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