Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

March 13, 2023 updated by: Noha Mansour, Mansoura University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Cilostazol 100 mg twice daily for treatment period
Drug: Cilostazol
Cilostazol 100 mg twice daily
Placebo Comparator: Control
placebo twice daily for treatment period
Drug: Placebo
Placebo twice daily

What is the study measuring?

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
Time Frame: 8 weeks post intervention
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Measures quality of life related to signs and symptoms of paclitaxel induced peripheral neuropathy
8 weeks
Serum nerve growth factor
Time Frame: 8 weeks
measuring serum level of nerve growth factor using ELISA KIT
8 weeks
Serum malionaldehyde
Time Frame: 8 weeks
measuring serum level of maliomaldehyde using spectrophometric kit
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: 8 weeks
any adverse/ side effect will be evaluated
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-395

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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