Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05298696
• Other study ID #: 2021-395
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 28, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Drug:
• Cilostazol
Cilostazol 100 mg twice daily
• Placebo
Placebo twice daily

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects	any adverse/ side effect will be evaluated	8 weeks
Primary	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	Severity of chemotherapy induced-peripheral neuropathy	Severity of paclitaxel induced peripheral neuropathy using VAS visual analogue scale.	8 weeks
Secondary	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
Secondary	Serum nerve growth factor	measuring serum level of nerve growth factor using ELISA KIT	8 weeks
Secondary	Serum malionaldehyde	measuring serum level of maliomaldehyde using spectrophometric kit	8 weeks