Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy

NCT06459193 | Completed Phase 1

• 1 other identifier: 2301006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Neuropathy Due to Chemotherapy

Keywords

Paclitaxel; Trimetazidine; quality of life; nerve growth factor; peripheral neuropathy

Outcome Measures

Primary Outcomes (2)

• 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. 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

  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 Outcomes (3)

• Changes in serum levels of biomarker namely nerve growth factor (NGF).

  at baseline and at end of 8 weeks

• Adverse effects of using trimetazidine in preventing Paclitaxel Induced Peripheral Neuropathy.

  at baseline and weekly up to 8 week

• Severity of chemotherapy induced-peripheral neuropathy.

  at baseline, at the end of 4 weeks and at the end of 8 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Trimetazidine Tablet 35 mg once daily for the treatment period

Drug: Trimetazidine

Control

PLACEBO COMPARATOR

Placebo once daily for the treatment period

Drug: Placebo

Interventions

Trimetazidine DRUG

Trimetazidine 35 mg tab once daily

Intervention

Placebo DRUG

Placebo once daily

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia Oncology Center

Minya, 61512, Egypt

Location

Related Publications (3)

• Khalefa HG, Shawki MA, Aboelhassan R, El Wakeel LM. Evaluation of the effect of N-acetylcysteine on the prevention and amelioration of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study. Breast Cancer Res Treat. 2020 Aug;183(1):117-125. doi: 10.1007/s10549-020-05762-8. Epub 2020 Jun 29.

  PMID: 32601973 BACKGROUND

• Haroun EA, Mansour NO, Eltantawy A, Shams MEE. Effect of cilostazol on preventing paclitaxel-induced neuropathy in patients with breast cancer: A randomized controlled trial. Pharmacotherapy. 2023 Sep;43(9):872-882. doi: 10.1002/phar.2830. Epub 2023 Jun 12.

  PMID: 37199288 BACKGROUND

• Hammad ASA, Sayed-Ahmed MM, Abdel Hafez SMN, Ibrahim ARN, Khalifa MMA, El-Daly M. Trimetazidine alleviates paclitaxel-induced peripheral neuropathy through modulation of TLR4/p38/NF-kappaB and klotho protein expression. Chem Biol Interact. 2023 May 1;376:110446. doi: 10.1016/j.cbi.2023.110446. Epub 2023 Mar 9.

  PMID: 36898573 BACKGROUND

MeSH Terms

Conditions

Hereditary Sensory and Autonomic Neuropathies; Peripheral Nervous System Diseases

Interventions

Trimetazidine

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Asmaa N. Iqbal Ahmed, Demonstrator

  Clinical Pharmacy Department, Faculty of Pharmacy, Minia University, Minia, Egypt.

  PRINCIPAL INVESTIGATOR

• Engy A. Wahsh, Asst. Prof.

  Clinical Pharmacy Department, Faculty of Pharmacy, October 6 University, Giza, Egypt

  STUDY DIRECTOR

• Fatma M. Mady, Professor

  Pharmaceutics department, Faculty of Pharmacy, Minia University, Minia, Egypt.

  STUDY CHAIR

• 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.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: June 23, 2024
• Primary Completion: January 28, 2025
• Study Completion: March 27, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)