Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
NCT ID: NCT06430814
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
188 participants
OBSERVATIONAL
2024-10-10
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Identification of Chemotherapy-induced Peripheral Neuropathy
NCT07148336
Evaluation by Oncologists of Strategies for the Prevention and Treatment of Chemotherapy-induced Peripheral Neuropathies
NCT03854864
Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy
NCT07095998
Chemotherapy Induced Neuropathy in Cancer Patients
NCT06491082
A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)
NCT04167319
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Breastcancer patients
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 three trial sites.
No intervention
No intervention
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention
No intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Odense University Hospital
OTHER
Sygehus Lillebaelt
OTHER
Sonderborg Hospital
OTHER_GOV
University of Southern Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ditte Bork Iversen
Role: STUDY_CHAIR
University of Southern Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Odense University Hospital
Odense, , Denmark
University Hospital of Southern Denmark, Sønderborg
Sønderborg, , Denmark
University Hospital of Southern Denmark, Vejle
Vejle, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AKF-403
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.