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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether desloratadine can prevent or ease nerve damage caused by taxane chemotherapy. It is for adults with stage I–III breast cancer who will receive taxanes. Researchers will compare desloratadine with a placebo, a look-alike pill with no drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with stage I–III breast cancer confirmed by a tissue test.
  • Plan to receive taxane chemotherapy for at least 12 weeks before or after surgery. Other chemotherapy, HER2-targeted drugs, or certain immune treatments may be given with it.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Have blood cell counts and liver and kidney test results that meet the study’s limits.
  • Have had no past taxane or platinum treatment. Diabetes is allowed if you have no nerve damage. Another cancer is allowed if it will not affect study safety or results.
  • Be able to understand and agree to join in writing, or have a legally authorized person give consent for you.
  • If you could become pregnant, have a negative pregnancy test within 14 days before the first study dose.
  • If able to have children, agree to use two barrier birth control methods or avoid sex before treatment, during treatment, and for 28 days after the last dose. Men must also avoid donating sperm during this time.

Who can't join

  • Already have peripheral neuropathy, or damage to nerves outside the brain and spinal cord.
  • Have received chemotherapy for your current breast cancer before the planned taxane treatment.
  • Are receiving another experimental drug.
  • Use antihistamines, medicines often used for allergies, during the study or in the 2 days before it. Have had an allergic reaction to a drug similar to desloratadine.
  • Have an uncontrolled illness or another serious condition that would make the study unsafe.
  • Are pregnant or breastfeeding.
  • Take probiotics, or regularly use laxatives or enemas to help pass stool.
  • Have used antibiotics within 4 weeks before signing up.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

NY