Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Southern Denmark
About this trial
Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
Willing to give informed consent
Scheduled to receive neo-adjuvant or adjuvant paclitaxel treatment
Able to speak and understand Danish
Disqualifiers
Neurodegenerative diseases (e.g., neuropathy from another cause, previous apoplexy, disc herniation
Type 1 or 2 diabetes
Pregnant
Breastfeeding
Trial population
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 four trial sites.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
188 Participants
are divided into 1 treatment groupGroup A: Breastcancer patients1 intervention
Trial outcomes
Primary outcomes
1
NFL level correlation
The primary endpoint of the study is if serum NFL\>100 pg/ml after first cycle (one cycle equals 3 weeks) of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.
Time frame
Before treatment start and during four cycles (one cycle equals 3 weeks)Secondary outcomes
1
Paclitaxel exposure
To measure if high concentration of paclitaxel exposure is correlated to high NFL level in blood
Time frame
Before treatment start and during four cycles (one cycle equals 3 weeks)2
Genes and PIPN
To measure if genetic variants in genes (e.g., CYP2C8\*3, EPHA4/5, FGD4) are associated with more server PIPN symptoms.
Time frame
Before treatment start and during four cycles (one cycle equals 3 weeks)3
Genes and NFL
To measure if genetic variants in genes (e.g., CYP2C8\*3, EPHA4/5, FGD4) are associated with high NFL concentration in blood.
Time frame
Before treatment start and during four cycles (one cycle equals 3 weeks)4
Genes and Paclitaxel
To measure if genetic variants in genes (e.g., CYP2C8\*3, EPHA4/5, FGD4) are associated with high paclitaxel concentration in blood.
Time frame
Before treatment start and during four cycles (one cycle equals 3 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern Denmark
Lead sponsor
Odense University Hospital
Collaborator
Sygehus Lillebaelt
Collaborator
Sonderborg Hospital
Collaborator
Source ClinicalTrials.gov