Clinical trial NCT06430814: Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
Official title: Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Sygehus Lillebaelt
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Sonderborg Hospital
First posted: 2024-05-28
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

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

Primary outcomes:
measure: NFL level correlation
timeFrame: Before treatment start and during four cycles (one cycle equals 3 weeks)
Secondary outcomes:
measure: Paclitaxel exposure
timeFrame: Before treatment start and during four cycles (one cycle equals 3 weeks)
measure: Genes and PIPN
timeFrame: Before treatment start and during four cycles (one cycle equals 3 weeks)
measure: Genes and NFL
timeFrame: Before treatment start and during four cycles (one cycle equals 3 weeks)
measure: Genes and Paclitaxel
timeFrame: Before treatment start and during four cycles (one cycle equals 3 weeks)
measure: Drug-drug interactions
timeFrame: Before treatment start and during four cycles (one cycle equals 3 weeks)
measure: Skin biopsies
timeFrame: Before treatment start and during four cycles (one cycle equals 3 weeks)
measure: IENFD
timeFrame: Before treatment start and during four cycles (one cycle equals 3 weeks)
measure: PHS
timeFrame: Before treatment start and during four cycles (one cycle equals 3 weeks)
measure: Nerve fiber dysfunction
timeFrame: Before treatment start and during four cycles (one cycle equals 3 weeks)
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
city: Sønderborg
country: Denmark
facility: University Hospital of Southern Denmark, Sønderborg
city: Vejle
country: Denmark
facility: University Hospital of Southern Denmark, Vejle
Study officials:
affiliation: University of Southern Denmark
name: Ditte Bork Iversen
role: STUDY_CHAIR
References: