Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer (DETOXp)
Montefiore Medical Center
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.
Description
Taxanes are frequently incorporated in first line chemotherapy regimens for breast cancer. Although taxane induces peripheral neuropathy (TIPN) is among the most common side effects of taxane treatment, currently there are no therapies that have consistently proven to be effective in preventing TIPN. TIPN involves a complex interplay of mechanisms which are not yet fully understood. However, neuroinflammation has been shown to be a critical component of the pathophysiology of TIPN. As a result, the discovery of novel therapies that can safely and efficiently attenuate the inflammatory drivers…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 inhibit…
Interventions
- DrugDesloratodine
Desloratadine 5mg PO every other day for 12 weeks. Desloratadine is a long- acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine inhibited histamine release from human mast cells.
- DrugPlacebo
Placebo daily PO for 12 weeks. Placebo is a lactose filler covered by a capsule.
Location
- Montefiore Medical CenterThe Bronx, New York