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Desloratadine to Prevent Neuropathy in Breast Cancer Patients

This study is looking at whether a drug called desloratadine can help prevent or reduce nerve damage (peripheral neuropathy) in people with breast cancer who are receiving taxane chemotherapy. Desloratadine is a type of antihistamine that has shown promise in animal studies for reducing inflammation. Researchers will compare desloratadine to a placebo (an inactive substance that looks like the drug) over 12 weeks. You may be able to join if you have stage I-III breast cancer and are scheduled to receive taxane-based chemotherapy for at least 12 weeks. The main goal is to see if desloratadine improves nerve damage scores and quality of life, as measured by questionnaires. The current recruitment status is unclear.

Study design
This is a double-blinded randomized controlled clinical trial, meaning neither you nor your doctor will know if you are receiving desloratadine or the placebo. The study plans to enroll 116 participants.
What's involved
You would take desloratadine 5mg by mouth every other day, or a placebo daily by mouth, for 12 weeks. Your neuropathy score will be measured from the start of the study until after you complete 12 weeks of chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
Your neuropathy score will be measured from the beginning of the study until after you complete 12 weeks of taxane chemotherapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07109817

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

Recruiting
PHASE2Ages 18+InterventionalSupportive care
Montefiore Medical Center
~116 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:DesloratodinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) Subscale Version 4 (FACT-GOG-NTX) neuropathy score
Measured over From baseline to after completion of 12 weeks of taxane chemotherapy

Conditions

Breast Cancer
Peripheral Neuropathy

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jesus R Anampa, MD, MS · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Jesus R Anampa, MD, MS
[email protected]
7184058505
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) Subscale Version 4 (FACT-GOG-NTX) neuropathy scoreFrom baseline to after completion of 12 weeks of taxane chemotherapy

    The patient-related-outcome based neurotoxicity will be assessed using the 11 items about neurotoxicity in the FACT/GOG-NTX questionnaire. For the FACT/GOG-NTX neuropathy, each item is scored from 0-4, and the neurotoxicity total score is the sum of the scores for the 11 items, and ranges from 0 to 44. Lower values of the FACT/GOG-NTX neurotoxicity total score indicate higher neurotoxicity. The FACT/GOG-NTX neurotoxicity total score will be analyzed as a continuous variable. Proper transformation to improve normality will be used if needed. Change in FACT/GOG-NTX neuropathy score will be defined as the difference in score values between baseline versus after 12 weeks of taxane chemotherapy.