Identifying patients at risk for nerve damage from paclitaxel

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate the neurofilament light chain (NFL) protein as a biomarker for predicting paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients. It will involve 188 participants who will provide blood samples before and during their treatment cycles, as well as skin biopsies at specified intervals. The primary goal is to determine if elevated serum NFL levels after the first cycle of paclitaxel can indicate a higher risk of early treatment termination due to peripheral neuropathy.

Why it matters

Who can join: the full rules

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

Where it's running

• Odense University Hospital
  Odense, Denmark Recruiting
• University Hospital of Southern Denmark, Sønderborg
  Sønderborg, Denmark Recruiting
• University Hospital of Southern Denmark, Vejle
  Vejle, Denmark Recruiting

Study contacts

• Study coordinator: Ditte Bork Iversen, MSc Pharm, PhD
• Email: dbiversen@health.sdu.dk
• Phone: +45 65 50 23 52

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cryotherapy during weekly paclitaxel to reduce chemotherapy-induced numbness and tingling

  This study tests whether applying cryotherapy to hands and feet during weekly paclitaxel helps prevent CIPN in women with breast cancer.

  Recruiting at 3 sites Azienda Sanitaria dell'Alto Adige · Bolzano, Bolzano and 3 other locations · NCT07780955

• SIR2501 plus Paclitaxel for solid tumors

  This Phase 2 study tests SIR2501 in adults with solid tumors who are starting paclitaxel chemotherapy to see if it is safe and tolerable and to explore its effect on chemotherapy-induced neuropathy.

  Recruiting at 3 sites Phase 2 Sironax USA, Inc. · Hollywood, Florida and 4 other locations · NCT07765446

• Non-invasive brain stimulation to help chemotherapy-induced nerve problems in cancer survivors

  This trial tests whether a gentle brain stimulation method (tDCS) can help reduce numbness, tingling, and pain from CIPN in cancer survivors who are not currently in treatment.

  Recruiting University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07673614

• Self-applied ear vagus nerve stimulation for chemotherapy-induced neuropathy

  Researchers are testing a small, at-home device that you wear on the ear to see if it eases nerve pain from chemotherapy.

  Recruiting University of Miami · Coral Gables, Florida · NCT07596030

• Blood extracellular vesicles to detect chemotherapy-related nerve damage.

  We will test whether tiny blood particles called extracellular vesicles can predict who will develop chemotherapy-induced peripheral neuropathy in adults receiving taxane, platinum, or antimitotic chemotherapy.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan · NCT07558447

• Virtual LASO-3 diet program to ease chemotherapy-related numbness and tingling

  This trial tests whether a virtual diet program that lowers added sugar and increases fiber and omega-3s can help cancer survivors who have numbness, tingling, or pain after neurotoxic chemotherapy.

  Recruiting University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07365007

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.