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.
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.
Study Type
OBSERVATIONAL
Enrollment
123
University of Alabama at Birmingham
Birmingham, Alabama, United States
UNC Hospitals Adult Oncology Clinics
Chapel Hill, North Carolina, United States
Change between baseline and the peak EORTC QLQ CIPN20 score during chemotherapy (continuous)
EORTC QLQ CIPN20
Time frame: 12 weeks
Incidence of grade 2 or higher CTCAE-CIPN during chemotherapy (binary)
CTCAE-CIPN
Time frame: 12 weeks
Dose reduction or discontinuation of chemotherapy (<85% of planned total dose delivered) (binary)
dose reduction or discontinuation
Time frame: 12 weeks
Dose reduction or discontinuation of the taxane portion of the chemotherapy, if administered separately from the rest of the chemotherapy agents (<85% of planned total dose delivered) (binary)
dose reduction or discontinuation
Time frame: 12 weeks
Change between baseline and the EORTC QLQ-CIPN20 score at one year after the last taxane-based chemotherapy dose (continuous)
EORTC QLQ-CIPN20
Time frame: 1 year
Presence of CIPN at one year after the last taxane based chemotherapy dose that is an EORTC QLQ-CIPN20 score of 3 points or higher than baseline (binary)
EORTC QLQ-CIPN20
Time frame: 1 year
Presence of grade 2 or higher CTCAE-CIPN at one year after the last taxane-based chemotherapy dose (binary)
CTCAE-CIPN
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.