Identifying patients at risk for nerve damage from paclitaxel
Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
This study is trying to see if measuring a specific protein in the blood can help predict which breast cancer patients might experience nerve damage from the chemotherapy drug paclitaxel.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 188 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Southern Denmark Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Odense and 2 other locations) |
| Trial ID | NCT06430814 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult breast cancer patients scheduled to receive paclitaxel treatment who can provide informed consent.
Not a fit: Patients with neurodegenerative diseases, diabetes, or those currently pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for nerve damage, allowing for better management of chemotherapy side effects.
How similar studies have performed: While the approach of using NFL as a biomarker is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Odense and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.