Efficacy of Cilostazol in Prevention of Peripheral Neuropathy
Safety and Efficacy of Cilostazol in Prevention of Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
1 other identifier
interventional
71
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2022
CompletedFirst Posted
Study publicly available on registry
March 28, 2022
CompletedStudy Start
First participant enrolled
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMarch 15, 2023
March 1, 2023
7 months
March 17, 2022
March 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Severity of chemotherapy induced-peripheral neuropathy
8 weeks
the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale
8 weeks
Serum nerve growth factor
8 weeks
Serum malionaldehyde
8 weeks
Other Outcomes (1)
Adverse effects
8 weeks
Study Arms (2)
Intervention
ACTIVE COMPARATORCilostazol 100 mg twice daily for treatment period
Control
PLACEBO COMPARATORplacebo twice daily for treatment period
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University
Al Mansurah, 35516, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Clinical Pharmacy
Study Record Dates
First Submitted
March 17, 2022
First Posted
March 28, 2022
Study Start
March 28, 2022
Primary Completion
October 30, 2022
Study Completion
December 30, 2022
Last Updated
March 15, 2023
Record last verified: 2023-03