Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Currently, there are no approved treatments by the US Food and Drug Administration or European Medicines Agency available for prevention or treatment of chemotherapy induced PN.

There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. These cells are myelin-forming peripheral glial cells which maintain nerve function. The intracellular cyclic adenosine monophosphate has a critical role in Schwann cell differentiation, there is a hypothesis that phosphodiesterase inhibitors, which increase the intracellular cAMP level, could prevent paclitaxel-induced dedifferentiation of Schwann cells. At the preclinical level, cilostazol potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated. Therefore, the aim of this study is to evaluate the effect of cilostazol on the amelioration of paclitaxel induced PN in breast cancer patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Cilostazol

Criteria

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 including vitamin B1, B6 and B12.

4. Patients receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.

5. Hypersensitivity to cilostazol.

6. Patients having heart failure of any stage.

7. Patients with active pathological bleeding or hemostatic disorders.