Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.
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.
Study Type
OBSERVATIONAL
Enrollment
188
No intervention
Odense University Hospital
Odense, Denmark
RECRUITINGUniversity Hospital of Southern Denmark, Sønderborg
Sønderborg, Denmark
RECRUITINGUniversity Hospital of Southern Denmark, Vejle
Vejle, Denmark
RECRUITINGNFL 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)
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)
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)
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)
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)
Drug-drug interactions
Investigate if and which specific drug-drug interactions are correlated to developing PIPN.
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
Skin biopsies
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Obtain skin biopsies from patients to elucidate which molecular mechanisms and phenotypes are associated with PIPN.
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
IENFD
Obtain skin biopsies at baseline and at the beginning of cycle 3 or 4 (one cycle equals 3 weeks) to assess if the intraepidermal nerve fiber density (IENFD) changes during paclitaxel treatment.
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
PHS
To assess whether the patients who have a sensation of heat during cooling of the skin (PHS) are also those who experience neuropathic pain.
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)
Nerve fiber dysfunction
To examine if increased NFL level is correlated to changes in small and large nerve fibers dysfunction.
Time frame: Before treatment start and during four cycles (one cycle equals 3 weeks)