Actively Recruiting
Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
Led by University of Southern Denmark · Updated on 2025-09-02
188
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Southern Denmark
Lead Sponsor
O
Odense University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to validate the protein neurofilament light chain (NFL) as a biomarker to predict the risk of developing peripheral neuropathy caused by paclitaxel treatment in patients with breast cancer. The study involves 188 patients receiving paclitaxel as neoadjuvant or adjuvant therapy. Researchers want to understand if serum NFL levels after the first treatment cycle can foresee early treatment stop due to neuropathy. Participants will continue their usual paclitaxel treatment cycles, up to a maximum of four cycles. Blood samples will be collected before treatment starts and before each new cycle to measure NFL levels. Additionally, skin biopsies will be taken before treatment and after the third or fourth cycle to assess nerve fiber health. No additional interventions will be given beyond standard care. Throughout the study, patients will undergo blood draws and skin biopsies at specified times to monitor NFL levels and nerve function. Researchers will assess how these measurements relate to paclitaxel exposure and neuropathy development. The main outcome is to see if NFL levels above 100 pg/ml after the first cycle predict early stopping of paclitaxel treatment due to neuropathy. The study is expected to continue until September 2027.
CONDITIONS
Brief Title
Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 naive patients
You will not qualify if you...
- Neurodegenerative diseases such as neuropathy from other causes, previous stroke, or disc herniation
- Type 1 or 2 diabetes
- Pregnant or breastfeeding
- Relapse of cancer diagnosis
- Diagnosed with HIV
- Participating in other clinical trials that change paclitaxel dose or aim to prevent neuropathic pain or decrease NFL level (except cooling gloves intervention)
- Previous treatment with neurotoxic chemotherapy
- Chronic pain from other causes
- Metastatic cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks (up to 4 treatment cycles, 3 weeks each)
Participants receiving paclitaxel treatment have blood samples and skin biopsies collected to monitor neurofilament light chain (NFL) levels and nerve function before and during treatment cycles.
1 visit before treatment start and 1 visit before each new treatment cycle (up to 4 visits total)
Trial Site Locations
Total: 3 locations
1
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
2
University Hospital of Southern Denmark, Sønderborg
Sønderborg, Denmark, 6400
Actively Recruiting
3
University Hospital of Southern Denmark, Vejle
Vejle, Denmark, 7100
Actively Recruiting
Research Team
D
Ditte Bork Iversen, MSc Pharm, PhD
T
Tore B. Stage, Prof
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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