Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy

Launched by UNIVERSITY OF SOUTHERN DENMARK · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how certain patients who receive a chemotherapy drug called paclitaxel might be at higher risk for developing a condition known as peripheral neuropathy. This condition can cause symptoms like tingling, pain, or numbness, usually in the hands and feet. The goal is to understand which women with breast cancer, who are starting treatment with paclitaxel, might experience these side effects so that doctors can provide better care.

To participate in the trial, women need to be at least 18 years old, be able to speak and understand Danish, and be scheduled to start paclitaxel treatment for their breast cancer. However, those with certain conditions, like diabetes or previous nerve issues, or those who are pregnant or breastfeeding, cannot join. Participants will be expected to give their consent and will be monitored throughout the study to gather information about their experiences with the treatment. This trial is currently recruiting participants, so if you or someone you know fits the criteria, it might be an opportunity to contribute to important research while receiving care.

Gender

FEMALE

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

Trial Officials