Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy

March 27, 2025 updated by: Asmaa Najm Iqbal Ahmed, Minia University

Evaluation of Trimetazidine in Alleviating Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients

This proof-of-concept study evaluated the effect of Trimetazidine on the incidence of paclitaxel-induced peripheral neuropathy in patients with breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chemotherapy-induced peripheral neuropathy (CIPN) is a major adverse effect of many commonly used chemotherapeutic agents that greatly affect patient quality of life. Paclitaxel (PTX), one of the main neurotoxic classes of anticancer drugs, is used to treat several types of solid tumors, including breast cancer. Development of PTX-induced peripheral neuropathy (PIPN) during cancer treatment requires dose reduction limiting its clinical benefits.

The only currently recognized prophylactic measure for chemotherapy-induced peripheral neuropathy (CIPN) is monitoring for pre-existing neuropathies and then the early detection of clinical symptoms of neuropathy in subjects undergoing neurotoxic chemotherapy treatment.

Preclinical data has shown that the neuroprotective effect of trimetazidine (TMZ) can attenuate PIPN.

TMZ has preclinical evidence about its preventive capacity against peripheral neuropathy. Which represents a possible prophylactic strategy for attenuating PIPN. TMZ is commercially available in various preparations that are relatively affordable and well-tolerated, making it a valid candidate for clinical evaluation.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61512
        • Minia Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Breast cancer patients who will receive paclitaxel.
  • 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, alcoholic disease, heart failure, pregnant or lactating women.
  • Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
  • Patients with contraindications to trimetazidine including Parkinson's disease, Parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Trimetazidine Tablet 35 mg once daily for the treatment period
Drug: Trimetazidine
Trimetazidine 35 mg tab once daily
Placebo Comparator: Control
Placebo once daily for the treatment period
Drug: Placebo
Placebo once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
Time Frame: weekly for up to 8 weeks
Number of patients reported neuropathy from paclitaxel. a 1 to 5 graded scale; where grade (1) is the minimum value and grade (5) is the maximum value, a greater grades mean greater symptomatic burden.
weekly for up to 8 weeks
Patient's Quality of Life
Time Frame: at baseline, at the end of 4 weeks and at the end of 8 weeks

measures the quality of life using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire.

A total score ranging from 0 (minimum value) to 44 (maximum value), where lower scores mean greater symptomatic burden.
at baseline, at the end of 4 weeks and at the end of 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in serum levels of biomarker namely nerve growth factor (NGF).
Time Frame: at baseline and at end of 8 weeks
measuring serum level of nerve growth factor using enzyme-linked immunoassay (ELISA) Kit.
at baseline and at end of 8 weeks
Adverse effects of using trimetazidine in preventing Paclitaxel Induced Peripheral Neuropathy.
Time Frame: at baseline and weekly up to 8 week
any adverse/ side effect will be evaluated.
at baseline and weekly up to 8 week
Severity of chemotherapy induced-peripheral neuropathy.
Time Frame: at baseline, at the end of 4 weeks and at the end of 8 weeks

The severity of paclitaxel-induced peripheral neuropathy using VAS visual analogue scale.

a 10-cm line that represents a continuum between "no pain" and "worst pain."
at baseline, at the end of 4 weeks and at the end of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: Asmaa N. Iqbal Ahmed, Demonstrator, Clinical pharmacy Department, Faculty of Pharmacy, Minia University, Minia, Egypt.
  • Study Director: Engy A. Wahsh, Asst. Prof., Clinical Pharmacy Department, Faculty of Pharmacy, October 6 University, Giza, Egypt
  • Study Chair: Fatma M. Mady, Professor, Pharmaceutics department, Faculty of Pharmacy, Minia University, Minia, Egypt.
  • Study Director: Eman M. Sadek, Lecturer, Clinical pharmacy Department, Faculty of Pharmacy, Minia University, Minia, Egypt.
  • Study Director: Ahmed Mostafa Abd-Elaziz, Lecturer, Department of Clinical Oncology, Faculty of Medicine, Minia University, Minia, Egypt.
  • Study Director: Noha Mahmood Abd-Allah, Lecturer, Department of Clinical Pathology, Faculty of Medicine, Minia University, Minia, Egypt.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2024

Primary Completion (Actual)

January 28, 2025

Study Completion (Actual)

March 27, 2025

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2301006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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