NCT04932031

Risk Prediction of Taxane Chemotherapy-Induced Peripheral Neuropathy

Systemic Assessment of CIPN Risk Using Molecular Aging Trajectories

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 123 (actual)
• Sponsor: Sapere Bio · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study to discover risk factors of chemotherapy-induced peripheral neuropathy (CIPN) in 350 patients with early stage breast cancer undergoing taxane-based chemotherapy at two main sites (University of North Carolina at Chapel Hill (UNC) Hospital, including Rex Hospital, and the University of Alabama at Birmingham (UAB) Hospital). The primary purpose of this study to explore patient- and procedure-based variables that identify patients at risk for developing CIPN during chemotherapy.

Detailed description

Chemotherapy-induced peripheral neuropathy is common and provokes pain, poor QoL, and loss of independence, as well as increases the risk of falls and opioid addiction. Beyond the inciting agents, risk factors for CIPN are not understood or systematically evaluated in clinical practice, precluding prevention. Therefore, a clinical decision tool to predict an individual patient's risk of neuropathy remains a critical unmet need. A diagnostic test that predicts CIPN risk in this clinical context would provide an essential clinical-decision tool to guide treatment and post-treatment care in breast cancer, prevent CIPN occurrence, and improve patient outcomes. Investigators' pilot data uncovered a strong association between cellular senescence and CIPN. In this prospective, observational study of participants with early-stage breast cancer, the investigators will assess the contribution of senescence and clinical variables. The investigators will determine the ability of these factors to identify patients at risk for CIPN during chemotherapy and up to one year after the last dose of taxane-based chemotherapy. This study will employ both patient- and clinician reported CIPN scoring systems.

Conditions

• Breast Cancer
• Chemotherapy-induced Peripheral Neuropathy
• Aging

Timeline

• Start date: 2022-05-25
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2021-06-18
• Last updated: 2023-11-03

Locations

2 sites across 1 country: United States