Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05298696

Enrollment

Registered

2022-03-28

Start date

2022-03-28

Completion date

2022-12-30

Last updated

2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Peripheral Neuropathy

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.

Interventions

DRUGCilostazol

Cilostazol 100 mg twice daily

DRUGPlacebo

Placebo twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Severity of chemotherapy induced-peripheral neuropathy	8 weeks	Severity of paclitaxel induced peripheral neuropathy using VAS visual analogue scale.
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
Serum malionaldehyde	8 weeks	measuring serum level of maliomaldehyde using spectrophometric kit

Other

Measure	Time frame	Description
Adverse effects	8 weeks	any adverse/ side effect will be evaluated

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026