Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

Mansoura University71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Peripheral Neuropathy Breast Cancer

Interventions

CilostazolDRUG

Cilostazol 100 mg twice daily

PlaceboDRUG

Placebo twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mansoura University

Al Mansurah, Egypt

Outcomes

Primary Outcomes

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

Time frame: 8 weeks post intervention

Secondary Outcomes

Severity of chemotherapy induced-peripheral neuropathy

Severity of paclitaxel induced peripheral neuropathy using VAS visual analogue scale.

Time frame: 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

Time frame: 8 weeks

Serum nerve growth factor

measuring serum level of nerve growth factor using ELISA KIT

Time frame: 8 weeks

Serum malionaldehyde

measuring serum level of maliomaldehyde using spectrophometric kit

Time frame: 8 weeks

Data from ClinicalTrials.gov

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