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Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

Primary Purpose

Peripheral Neuropathy, Breast Cancer

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Cilostazol

Placebo

About this trial

This is an interventional prevention trial for Peripheral Neuropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Cilostazol 100 mg twice daily for treatment period

placebo twice daily for treatment period

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Severity of chemotherapy induced-peripheral neuropathy

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

Measures quality of life related to signs and symptoms of paclitaxel induced peripheral neuropathy

Serum nerve growth factor

measuring serum level of nerve growth factor using ELISA KIT

Serum malionaldehyde

measuring serum level of maliomaldehyde using spectrophometric kit

Full Information

NCT ID

NCT05298696

First Posted

March 17, 2022

Last Updated

March 13, 2023

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05298696

Brief Title

Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

March 28, 2022 (Actual)

Primary Completion Date

October 30, 2022 (Actual)

Study Completion Date

December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Neuropathy, Breast Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Active Comparator

Arm Description

Cilostazol 100 mg twice daily for treatment period

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

placebo twice daily for treatment period

Intervention Type

Drug

Intervention Name(s)

Cilostazol

Intervention Description

Cilostazol 100 mg twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo twice daily

Primary Outcome Measure Information:

Title

Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria

Description

Number of patients reported neuropathy from paclitaxel

Time Frame

8 weeks post intervention

Secondary Outcome Measure Information:

Title

Severity of chemotherapy induced-peripheral neuropathy

Description

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

Time Frame

8 weeks

Title

the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale

Description

Measures quality of life related to signs and symptoms of paclitaxel induced peripheral neuropathy

Time Frame

8 weeks

Title

Serum nerve growth factor

Description

measuring serum level of nerve growth factor using ELISA KIT

Time Frame

8 weeks

Title

Serum malionaldehyde

Description

measuring serum level of maliomaldehyde using spectrophometric kit

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

Adverse effects

Description

any adverse/ side effect will be evaluated

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Mansoura University

City

Mansoura

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

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