Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Cilostazol in Prevention of Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients

Conditions
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Peripheral Neuropathy, Breast Cancer

Intervention / Treatment
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* Drug: Cilostazol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer patients who will receive paclitaxel post-anthracycline therapy. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2. 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: Patients with signs and symptoms of clinical neuropathy at baseline. Patients with diabetes mellitus or alcoholic disease. Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Cilostazol 100 mg twice daily for treatment period | Drug: Cilostazol<br>* Cilostazol 100 mg twice daily<br>|
| Placebo Comparator: Control<br>placebo twice daily for treatment period | Drug: Placebo<br>* Placebo twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria | Number of patients reported neuropathy from paclitaxel | 8 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of chemotherapy induced-peripheral neuropathy | Severity of paclitaxel induced peripheral neuropathy using VAS visual analogue scale. | 8 weeks | 
| the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale | Measures quality of life related to signs and symptoms of paclitaxel induced peripheral neuropathy | 8 weeks | 
| Serum nerve growth factor | measuring serum level of nerve growth factor using ELISA KIT | 8 weeks | 
| Serum malionaldehyde | measuring serum level of maliomaldehyde using spectrophometric kit | 8 weeks |