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

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.

Eligibility

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:
* absolute neutrophil count ≥1,000/microliter (mcL)
* platelets ≥100,000/mcL
* total bilirubin ≤ institutional upper limit of normal (ULN)
* AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
* Creatinine ≤ institutional ULN
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with prior diagnosis of diabetes mellitus are allowed if the patient has no peripheral neuropathy
* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
* Patients must not have received prior taxane or platinum therapy
* Women of childbearing potential must have a negative pregnancy test: serum or urine beta human chorionic gonadotropin (hCG) within 14 days prior to first dose of study treatment
* Potential fertile subjects must agree to use adequate contraception (double barrier methods of birth control or abstinence) prior to start of treatment, for the duration of treatment, and 28 days after last study medication dose. If male, must also agree to refrain from donating sperm during this period

Exclusion Criteria:

* 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
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to desloratadine
* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
* Pregnant or breastfeeding women are not allowed in the study
* Patients who are taking probiotics
* Patients who are using chronic laxatives or enema
* Patients who used antibiotics within 4 weeks of registration

Conditions3

Interventions1

Locations1 site

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