Recruiting

Phase 2

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

Sponsor:

Montefiore Medical Center

Code:

NCT07109817

Conditions

Breast Cancer

Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Desloratodine

Placebo

Study Details

Brief 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.

Conditions

Breast Cancer

Peripheral Neuropathy

Study ID

NCT07109817

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Paclitaxel or Docetaxel for 12 weeks and Placebo

experimental: Desloratodine

Paclitaxel or Docetaxel for 12 weeks and Desloratadine

Interventions

Desloratodine

Desloratadine 5mg PO every other day for 12 weeks. Desloratadine is a long- acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine inhibited histamine release from human mast cells.

Placebo

Placebo daily PO for 12 weeks. Placebo is a lactose filler covered by a capsule.

Primary outcome measure

Change in Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) Subscale Version 4 (FACT-GOG-NTX) neuropathy score [ Time Frame: From baseline to after completion of 12 weeks of taxane chemotherapy ]

Central Contacts and Locations

Central contacts

Jesus R Anampa, MD, MS

7184058505 janampa@montefiore.org

Rikin Ghandi

9149531890 rikin.gandhi@einsteinmed.edu

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Jesus Anampa, MD, MS

718-405-8505 janampa@montefiore.org

Rikin Ghandi

rikin.gandhi@einsteinmed.edu

More Information

Sponsor

Montefiore Medical Center

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

Patient reported outcomes
Biomarkers
Taxane
Neuroinflammatory
Cytokine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-08-26.