Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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%)
Disqualifiers
Patients with prior diagnosis of peripheral neuropathy
Patients who received chemotherapy for the current breast cancer diagnosis before the planned taxane-based regimen
Patients who are receiving any other investigation agents
Patients with concurrent use of antihistamines during or for 2 days prior to the study period
Trial design
Treatments tested in this trial
- Desloratodine
- Placebo
Treatment groups
116 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov