Clinical trial · Interventional
Efficacy of Cilostazol in Prevention of Peripheral Neuropathy
Safety and Efficacy of Cilostazol in Prevention of Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
NCT05298696CI-TRIAL-00064699completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. At the preclinical level, cilostazol potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cilostazol | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention
- description
- Cilostazol 100 mg twice daily for treatment period
- interventionNames
- Drug: Cilostazol
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- placebo twice daily for treatment period
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
- timeFrame
- 8 weeks post intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Breast cancer patients who will receive paclitaxel post-anthracycline therapy. 2. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2. 3. Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin \<1.5 mg/dl), renal function (creatinine \< 1.5 mg/dl). Exclusion Criteria: 1. Patients with signs and symptoms of clinical neuropathy at baseline. 2. Patients with diabetes mellitus or alcoholic disease. 3. Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
References
Publications (0)
Data not yet available
No reference posted for this study.