Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

Phase 1

Completed

• Conditions: Peripheral Neuropathy; Breast Cancer
• Interventions: Drug: Cilostazol; Drug: Placebo

• Registration Number: NCT05298696
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-17
• Study Start: 2022-03-28
• Study First Posted: 2022-03-28
• Primary Completion: 2022-10-30
• Study Completion: 2022-12-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Cilostazol	Cilostazol 100 mg twice daily for treatment period
Control	Placebo	placebo twice daily for treatment period

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt