Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07109817

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

Led by Montefiore Medical Center · Updated on 2026-05-29

116

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether desloratadine can reduce the development of peripheral neuropathy in patients with breast cancer who are receiving taxane chemotherapy. This randomized, double-blinded, controlled trial focuses on preventing or lessening taxane-induced peripheral neuropathy (TIPN), a common and distressing side effect. The study also explores inflammatory biomarkers and the gut microbiome's role in TIPN, aiming to improve understanding and potential prevention strategies. Participants will receive either desloratadine 5 mg or a placebo every other day for 12 weeks alongside their standard taxane chemotherapy (paclitaxel or docetaxel). Desloratadine is a histamine H1 receptor antagonist thought to reduce inflammation linked to TIPN. The study compares these two groups to assess whether desloratadine can prevent or improve neuropathy symptoms and examines its effects on biological markers related to inflammation and nerve health. During the study, participants will be monitored through validated neurotoxicity and quality of life questionnaires from baseline through 12 weeks of chemotherapy and beyond. Researchers will assess neuropathy severity, quality of life, chemotherapy dose adjustments, and biological markers. Follow-up assessments occur at 24 weeks and 12 months after chemotherapy. Participants will be closely observed for treatment effects, safety, and changes in neuropathy symptoms throughout the trial period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have histologically confirmed breast cancer, stage I-III as per AJCC 8th edition (Anatomic Staging)
  • Planned to receive taxane-based chemotherapy regimen for at least 12 weeks (adjuvant or neoadjuvant), including combinations with other chemotherapy, anti-HER2 therapy, or immune checkpoint inhibitors
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (Karnofsky 60% or higher)
  • Adequate organ and marrow function as defined by specific blood count and chemistry levels
  • Patients with prior or concurrent malignancies that do not interfere with safety or efficacy assessment
  • Patients with prior diabetes allowed if no peripheral neuropathy present
  • Ability and willingness to provide informed consent
  • No prior taxane or platinum therapy
  • Women of childbearing potential must have negative pregnancy test within 14 days before first dose
  • Agree to use adequate contraception or abstinence during treatment and 28 days after last dose; males agree to refrain from sperm donation during this period
Not Eligible

You will not qualify if you...

  • Prior diagnosis of peripheral neuropathy
  • Previous chemotherapy for current breast cancer diagnosis before planned taxane regimen
  • Receiving other investigational agents
  • Use of antihistamines during or within 2 days before study
  • History of allergic reactions to desloratadine or similar compounds
  • Uncontrolled illness or significant conditions making participation unsafe
  • Pregnant or breastfeeding women
  • Use of probiotics
  • Use of chronic laxatives or enemas
  • Antibiotic use within 4 weeks prior to registration

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive either desloratadine or placebo alongside taxane-based chemotherapy to prevent peripheral neuropathy.

Weekly visits for up to 12 weeks

Follow-up

Duration - Up to 12 months

Participants are monitored for neuropathy symptoms and quality of life after completing chemotherapy.

Visits at 12 weeks, 24 weeks, and 12 months after treatment completion

Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

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Research Team

J

Jesus R Anampa, MD, MS

R

Rikin Ghandi

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Anthracycline-containing and taxane-containing chemotherapy for early-stage operable breast cancer: a patient-level meta-analysis of 100 000 women from 86 randomised trials.

Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Electronic address: bc.overview@ctsu.ox.ac.uk, Early Breast Cancer Trialists’ Collaborative Group (EBCTCG)

https://pubmed.ncbi.nlm.nih.gov/37061269

Plant antitumor agents. VI. The isolation and structure of taxol, a novel antileukemic and antitumor agent from Taxus brevifolia.

M C Wani, H L Taylor, M E Wall...

https://pubmed.ncbi.nlm.nih.gov/5553076