Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Chemotherapy-induced Peripheral Neuropathy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.
Detailed description
The primary aim of this study is to validate the protein neurofilament light chain (NFL) as a biomarker of the side effect paclitaxel-induced peripheral neuropathy (PIPN) and its utility in predicting this side effect in patients with breast cancer. The investigators want to include 188 patients at four different trial sites. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles.
Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain (NFL) before and during treatment. The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4.
The primary endpoint of the study is if serum NFL\>100 pg/ml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.
Interventions
- Other No intervention
No intervention
Primary outcome measures
- NFL level correlation [Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)]
Secondary outcome measures (9)
- Paclitaxel exposure [Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Genes and PIPN [Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Genes and NFL [Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Genes and Paclitaxel [Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Drug-drug interactions [Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Skin biopsies [Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- IENFD [Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- PHS [Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Nerve fiber dysfunction [Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Denmark · 3 centers
- Odense University Hospital — Odense
- University Hospital of Southern Denmark, Sønderborg — Sønderborg
- University Hospital of Southern Denmark, Vejle — Vejle
Identifiers
NCT: NCT06430814 · AKF-403