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NCT07109817 · ClinicalTrials.gov registry record · Phase 2
Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer
A Phase 2 study, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT07109817: Recruiting Phase 2 study, sponsored by Montefiore Medical Center.
NCT07109817 is a Phase 2 study that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07109817, a Phase 2 study, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study 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.
Primary Outcome
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 transformati
Interventions
- DRUG Placebo
- DRUG Desloratodine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2026-06 |
| Est. Completion | 2030-09 |
| Phase | Phase 2 |
What NCT07109817 shows while recruiting
NCT07109817 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07109817 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07109817 about?
NCT07109817 is a clinical study titled "Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer". 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...
What is the current status of trial NCT07109817?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2026-06. Estimated completion is 2030-09.
What interventions are being tested in trial NCT07109817?
The interventions under investigation include: Placebo (DRUG), Desloratodine (DRUG).
Who is sponsoring clinical trial NCT07109817?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07109817's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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