Risk Prediction of Taxane Chemotherapy-Induced Peripheral Neuropathy
Stopped early
Conditions studied: Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Aging
In brief
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.
Key facts
- Study ID
- NCT04932031
- Run by
- Sapere Bio
- People needed
- 123
- Starts
- 2022-05-25
- Expected to finish
- 2023-11-01
- Last updated by the study team
- 2023-11-03
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Study participants must meet all of the following inclusion criteria to participate in the study:
- Adult female study participants (≥18 years) with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel
- Study participants must be capable and willing to provide informed consent, and be willing and able to complete the study questionnaires during the study
You may not qualify if…
- Study participants who fulfill any of the following criteria will be excluded:
- Patients with metastatic breast cancer
- History of other cancers (except squamous and basal cell carcinoma)
- Autoimmune disorders
- Presence of major active infection for which antibiotics and/or antivirals are prescribed within the last 14 days (chronic or acute, eg, sepsis, HIV, pneumonia, active COVID infection)
- Pregnant women
- Participation in an additional study at the time of enrollment where the intervention could potentially alter CIPN risk (unless in the control arm)
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- UNC Hospitals Adult Oncology Clinics — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.