Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy

NCT ID: NCT06459193

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-23
• Study Completion Date: 2025-03-27

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.

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.

Conditions

Peripheral Neuropathy Due to Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Trimetazidine Tablet 35 mg once daily for the treatment period

Group Type: ACTIVE_COMPARATOR

Trimetazidine

Intervention Type: DRUG

Trimetazidine 35 mg tab once daily

Control

Placebo once daily for the treatment period

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo once daily

Interventions

Trimetazidine

Trimetazidine 35 mg tab once daily

Intervention Type: DRUG

Placebo

Placebo once daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Najm Iqbal Ahmed

Demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asmaa N. Iqbal Ahmed, Demonstrator

Role: PRINCIPAL_INVESTIGATOR

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

Engy A. Wahsh, Asst. Prof.

Role: STUDY_DIRECTOR

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

Fatma M. Mady, Professor

Role: STUDY_CHAIR

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

Eman M. Sadek, Lecturer

Role: STUDY_DIRECTOR

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

Ahmed Mostafa Abd-Elaziz, Lecturer

Role: STUDY_DIRECTOR

Department of Clinical Oncology, Faculty of Medicine, Minia University, Minia, Egypt.

Noha Mahmood Abd-Allah, Lecturer

Role: STUDY_DIRECTOR

Department of Clinical Pathology, Faculty of Medicine, Minia University, Minia, Egypt.

Locations

Minia Oncology Center

Minya, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 32601973 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37199288 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36898573 (View on PubMed)

Other Identifiers

2301006

Identifier Type: -

Identifier Source: org_study_id