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Phase 2
Age: 18Years +
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ID07109817

Study of Desloratadine to Prevent Peripheral Neuropathy in Breast Cancer Patients Receiving Taxane Chemotherapy

Led by Montefiore Medical Center · Updated on 2026-05-29

116

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether desloratadine can reduce the development of peripheral neuropathy in patients with breast cancer who are receiving taxane chemotherapy. This randomized, double-blinded, controlled trial focuses on preventing or lessening taxane-induced peripheral neuropathy TIPN, a common and distressing side effect. The study also explores inflammatory biomarkers and the gut microbiomes role in TIPN, aiming to improve understanding and potential prevention strategies. Participants will receive either desloratadine 5 mg or a placebo every other day for 12 weeks alongside their standard taxane chemotherapy paclitaxel or docetaxel. Desloratadine is a histamine H1 receptor antagonist thought to reduce inflammation linked to TIPN. The study compares these two groups to assess whether desloratadine can prevent or improve neuropathy symptoms and examines its effects on biological markers related to inflammation and nerve health. During the study, participants will be monitored through validated neurotoxicity and quality of life questionnaires from baseline through 12 weeks of chemotherapy and beyond. Researchers will assess neuropathy severity, quality of life, chemotherapy dose adjustments, and biological markers. Follow-up assessments occur at 24 weeks and 12 months after chemotherapy. Participants will be closely observed for treatment effects, safety, and changes in neuropathy symptoms throughout the trial period.

CONDITIONS

Brief Title

Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer

Research Team

J

Jesus R Anampa, MD, MS

R

Rikin Ghandi

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