Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Canc
This is a double-blinded randomized controlled clinical trial that aims to study if desloratadine can reduce rates of peripheral neuropathy development in patients with breast cancer receiving taxane chemotherapy. Researchers will compare desloratadine to a placebo (look-alike substance with no drug) and use validated
| Condition(s) | Breast Cancer, Peripheral Neuropathy |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a double-blinded randomized controlled clinical trial that aims to study if desloratadine can reduce rates of peripheral neuropathy development in patients with breast cancer receiving taxane chemotherapy. Researchers will compare desloratadine to a placebo (look-alike substance with no drug) and use validated neurotoxicity and quality of life questionnaires to determine if desloratadine can be used to prevent or make taxane induced peripheral neuropathy (TPIN) symptoms better. |
| Who can participate | Inclusion Criteria: * Patients must have histologically confirmed breast cancer, stage I-III as per the American Joint Committee on Cancer (AJCC) 8th edition (Anatomic Staging) * Patients must be planned to receive taxane-based regimen for breast cancer (Adjuvant or neoadjuvant) of at least 12 weeks duration. Patients planned to receive taxanes in combination with other chemotherapy drugs (including platinums) are eligible. Patients planned to receive taxanes plus single or dual antiher2 therapy are also eligible. Patients planned to receive taxane-based regimen with immune checkpoint inhibitors are also allowed * Age ≥18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%) * Patients must have an adequate organ and marrow function as defined below: * ab |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Montefiore Medical Center |
| Locations | The Bronx, New York, United States |
| Start date | 2026-06 |
| NCT ID | NCT07109817 |
| Official listing | https://clinicaltrials.gov/study/NCT07109817 |