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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT07109817
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Desloratodine — DRUG
    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 — DRUG
    Placebo daily PO for 12 weeks. Placebo is a lactose filler covered by a capsule.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2030

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Placebo Comparator: Placebo
    Paclitaxel or Docetaxel for 12 weeks and Placebo
  • Experimental: Desloratodine
    Paclitaxel or Docetaxel for 12 weeks and Desloratadine

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

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10467
Jesus Anampa, MD, MS
[email protected]
718-405-8505
Rikin Ghandi
[email protected]

Find similar trials in The Bronx, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Montefiore Medical Center· The Bronx, NY

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