Chemotherapy-induced peripheral neurotoxicity: a critical analysis.
Susanna B Park, David Goldstein, Arun V Krishnan...
https://pubmed.ncbi.nlm.nih.gov/24590861/Actively Recruiting
Led by Montefiore Medical Center · Updated on 2026-05-29
116
Participants Needed
1
Research Sites
52 weeks
Total Duration
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 microbiomes 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
Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer
J
Jesus R Anampa, MD, MS
R
Rikin Ghandi
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Montefiore Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Desloratadine + Taxane Chemotherapy | Placebo + Taxane Chemotherapy |
|---|---|---|
| What it is | Desloratadine is a tricyclic, selective H1 histamine receptor antagonist taken orally every other day during taxane-based chemotherapy for breast cancer. It is studied for its potential to prevent or limit the onset of chemotherapy-induced peripheral neuropathy. | Placebo consists of an oral inactive capsule visually identical to desloratadine, taken every other day during the same chemotherapy schedule. |
| Role in trial | Investigational oral agent tested for the prevention of taxane-induced peripheral neuropathy when given alongside chemotherapy. | Comparator arm to assess the effectiveness of desloratadine; receives all standard chemotherapy and trial procedures, but instead of active antihistamine receives placebo. |
| Primary use | Being studied as an oral preventive agent for taxane-induced peripheral neuropathy in breast cancer patients undergoing chemotherapy. | Serves as a control; has no preventive effect and is used to measure the benefit of desloratadine. |
| How it is given | Desloratadine 5 mg by mouth every other day, starting with the first dose of taxane and continuing for the 12-week chemotherapy period. | Placebo capsule taken on the same schedule as desloratadine for 12 weeks. |
| Evidence status | As of now, there is no published evidence in humans supporting desloratadine for prevention of taxane-induced neuropathy. Preclinical studies in mouse models suggest a benefit, but human evidence remains unestablished. | Receiving placebo provides no active neuropathy prevention. The control arm enables evaluation of the effect of desloratadine compared to background risk. |
| Important limitations | Potential benefits are based on experimental evidence from animal models and not yet validated in human clinical studies; unknown risks or interactions may exist when using desloratadine in this setting. | As a non-active control, placebo offers no preventive benefit and does not address neuropathy risk associated with taxane chemotherapy. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either desloratadine or placebo alongside taxane-based chemotherapy to prevent peripheral neuropathy.
Weekly visits for up to 12 weeks
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
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Susanna B Park, David Goldstein, Arun V Krishnan...
https://pubmed.ncbi.nlm.nih.gov/24590861/Jennifer Le-Rademacher, Rahul Kanwar, Drew Seisler...
https://pubmed.ncbi.nlm.nih.gov/28634656/Jian Lu, Xue-Jian Zhao, Yuan Ruan...
https://pubmed.ncbi.nlm.nih.gov/38789495/Dawn L Hershman, Joseph M Unger, Katherine D Crew...
https://pubmed.ncbi.nlm.nih.gov/23733756/Xiaojuan Liu, Raquel Tonello, Yuejuan Ling...
https://pubmed.ncbi.nlm.nih.gov/31707979/Martha M Rumore, David A Schlichting
https://pubmed.ncbi.nlm.nih.gov/2872645/María M Escribese, Domenico Rosace, Tomas Chivato...
https://pubmed.ncbi.nlm.nih.gov/28533777/A Cüneyt Ozaktay, John M Cavanaugh, Ibrahim Asik...
https://pubmed.ncbi.nlm.nih.gov/12384756/Chunyan Guo, Li Sun, Xueping Chen...
https://pubmed.ncbi.nlm.nih.gov/25206509/William J Gradishar
https://pubmed.ncbi.nlm.nih.gov/16722814/Montefiore Medical Center
Lead Sponsor