Clinical trial · Observational
Risk Prediction of Taxane Chemotherapy-Induced Peripheral Neuropathy
Systemic Assessment of CIPN Risk Using Molecular Aging Trajectories
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): under enrollment for primary endpoint analysis
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aging | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Study group
- description
- Adult females with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel
Primary outcomes (1)
- measure
- Change between baseline and the peak EORTC QLQ CIPN20 score during chemotherapy (continuous)
- timeFrame
- 12 weeks
- description
- EORTC QLQ CIPN20
Secondary outcomes (6)
- measure
- Incidence of grade 2 or higher CTCAE-CIPN during chemotherapy (binary)
- timeFrame
- 12 weeks
- description
- CTCAE-CIPN
- measure
- Dose reduction or discontinuation of chemotherapy (<85% of planned total dose delivered) (binary)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: 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)
References
Publications (0)
Data not yet available