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OpenTrials
Completed

NCT Number: NCT05298696

Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

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.

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Key information

Conditions

Peripheral Neuropathy Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Cilostazol

Drug

Cilostazol 100 mg twice daily

Placebo

Drug

Placebo twice daily

Primary outcomes

  1. 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

Secondary outcomes

  1. Severity of chemotherapy induced-peripheral neuropathy

    Time frame: 8 weeks

    Severity of paclitaxel induced peripheral neuropathy using VAS visual analogue scale.

  2. 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

  3. Serum nerve growth factor

    Time frame: 8 weeks

    measuring serum level of nerve growth factor using ELISA KIT

  4. Serum malionaldehyde

    Time frame: 8 weeks

    measuring serum level of maliomaldehyde using spectrophometric kit

Other outcomes

  1. Adverse effects

    Time frame: 8 weeks

    any adverse/ side effect will be evaluated

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2022
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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