Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430814
• Other study ID #: AKF-403
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: University of Southern Denmark
• Contact: Ditte Bork Iversen, MSc Pharm, PhD
• Phone: +45 65 50 23 52
• Email: dbiversen[@]health.sdu.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 188
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of Southern Denmark	Esbjerg Hospital, Odense University Hospital, Sonderborg Hospital, Sygehus Lillebaelt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before treatment start and during four cycles (one cycle equals 3 weeks)
Secondary	Paclitaxel exposure	To measure if high concentration of paclitaxel exposure is correlated to high NFL level in blood	Before treatment start and during four cycles (one cycle equals 3 weeks)
Secondary	Genes and PIPN	To measure if genetic variants in genes (e.g., CYP2C8*3, EPHA4/5, FGD4) are associated with more server PIPN symptoms.	Before treatment start and during four cycles (one cycle equals 3 weeks)
Secondary	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.	Before treatment start and during four cycles (one cycle equals 3 weeks)
Secondary	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.	Before treatment start and during four cycles (one cycle equals 3 weeks)
Secondary	Drug-drug interactions	Investigate if and which specific drug-drug interactions are correlated to developing PIPN.	Before treatment start and during four cycles (one cycle equals 3 weeks)
Secondary	Skin biopsies	Obtain skin biopsies from patients to elucidate which molecular mechanisms and phenotypes are associated with PIPN.	Before treatment start and during four cycles (one cycle equals 3 weeks)
Secondary	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.	Before treatment start and during four cycles (one cycle equals 3 weeks)
Secondary	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.	Before treatment start and during four cycles (one cycle equals 3 weeks)
Secondary	Nerve fiber dysfunction	To examine if increased NFL level is correlated to changes in small and large nerve fibers dysfunction.	Before treatment start and during four cycles (one cycle equals 3 weeks)