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This proof-of-concept study evaluated the effect of Trimetazidine on the incidence of paclitaxel-induced peripheral neuropathy in patients with breast cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Trimetazidine Tablet 35 mg once daily for the treatment period |
|
| Control | Placebo Comparator | Placebo once daily for the treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimetazidine | Drug | Trimetazidine 35 mg tab once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum levels of biomarker namely nerve growth factor (NGF). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia Oncology Center | Minya | 61512 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32601973 | Background | 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. | |
| 37199288 |
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| ID | Term |
|---|---|
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D014292 | Trimetazidine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
Placebo once daily |
|
any adverse/ side effect will be evaluated. |
| at baseline and weekly up to 8 week |
| Severity of chemotherapy induced-peripheral neuropathy. | 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 |
| 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. |
| 36898573 | 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. |
| 41704280 | Derived | Iqbal AN, Mady FM, Sadek EM, Abdullah NM, Abdel-Azeez AM, Shorog E, Wahsh EA. Evaluation of trimetazidine in alleviating paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial. Front Pharmacol. 2026 Feb 2;17:1748399. doi: 10.3389/fphar.2026.1748399. eCollection 2026. |
| D011115 | Polyneuropathies |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |