Desloratadine to see if it can prevent nerve damage from taxane chemotherapy in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, double-blind trial compares desloratadine to a placebo in patients with stage I–III breast cancer who are planned to receive taxane-based chemotherapy. Researchers will track neuropathy symptoms and quality of life using validated questionnaires, and will also measure inflammatory biomarkers to explore potential mechanisms. The study builds on animal data suggesting desloratadine may reduce neuroinflammation involved in TIPN. Enrollment is at Montefiore Medical Center in the Bronx, with participants receiving taxane-containing regimens for 12 weeks or longer. The goal is to determine whether desloratadine can prevent or lessen TIPN and improve patient well-being during chemotherapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Montefiore Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Jesus R Anampa, MD, MS — Montefiore Medical Center
• Study coordinator: Jesus R Anampa, MD, MS
• Email: janampa@montefiore.org
• Phone: 7184058505

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.