Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy

University of Southern Denmark (SDU)

Status: Enrolling

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06430814

AKF-403

Details and patient eligibility

About

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

Full 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.

Enrollment: 188 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

188 participants in 1 patient group

Breastcancer patients

Description:

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.

Treatment:

Other: No intervention