This phase II trial tests how well desloratadine works in preventing peripheral neuropathy from exposure to taxane chemotherapy in patients with stage I-III breast cancer. Taxane chemotherapy drugs (paclitaxel and docetaxel) are commonly used to treat breast cancer. Peripheral neuropathy is one of the major adverse side effects of taxane therapy. Peripheral neuropathy can present in the hands and feet with sensory and motor changes including, numbness, tingling, burning, pain, impaired coordination, and weakness. Peripheral neuropathy can negatively impact daily activity and quality of life and can lead to dose reductions, delays and early discontinuation of treatment. Currently, there is no proven effective method to prevent taxane-induced peripheral neuropathy (TIPN). Desloratadine is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms. Giving desloratadine may prevent TIPN in patients with stage I-III breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07109817.
Locations matching your search criteria
United States
New York
Bronx
Montefiore Medical Center-Weiler HospitalStatus: Approved
Contact: Jesus Del Santo Anampa Mesias
Phone: 718-405-8505
PRIMARY OBJECTIVE:
I. To compare the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group Neurotoxicity (GOG-NTX) neuropathy score between desloratadine and placebo in patients with early breast cancer receiving taxane-based regimens.
SECONDARY OBJECTIVES:
I. To compare gut microbiome signatures between patients with and without taxane-induced peripheral neuropathy (TIPN), and further comparison stratified by desloratadine use.
II. To compare levels of serum inflammatory biomarkers between patients with and without TIPN, and further comparison stratified by desloratadine use.
III. To assess the effect of TIPN on quality of life, and further comparison stratified by desloratadine use.
IV. To assess the association between allostatic load and TIPN, and further stratified analysis by desloratadine use.
V. To compare the rate of TIPN among race/ethnic groups and assess the effect of desloratadine to prevent TIPN by race/ethnic groups.
VI. To assess whether differences in racial/ethnic gut microbiome signatures are associated with differences in rates of TIPN among racial/ethnic groups.
VII. To assess whether differences in racial/ethnic serum inflammatory biomarkers are associated with differences in rates of TIPN among racial/ethnic groups.
VIII. To assess the effect of desloratadine on pathological complete response (pCR) in patients receiving taxane-based regimens.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive desloratadine orally (PO) once daily (QD) as well as standard of care paclitaxel or docetaxel for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.
ARM II: Patients receive placebo PO QD as well as standard of care paclitaxel or docetaxel for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed for 30 days, at 24 weeks, and at 12 months after starting taxane.
Lead OrganizationMontefiore Medical Center-Weiler Hospital
Principal InvestigatorJesus Del Santo Anampa Mesias
