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NCT Number: NCT06459193

Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy

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

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Key information

Conditions

Peripheral Neuropathy Due to Chemotherapy Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Minia Oncology Center

Minya, 61512, Egypt

About this study

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.

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.
  • 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.

Treatment and study plan

Trimetazidine

Drug

Trimetazidine 35 mg tab once daily

Placebo

Drug

Placebo once 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: 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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."

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2024
Registry last updated
Mar 30, 2025

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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