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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
60
Trimetazidine 35 mg tab once daily
Placebo once daily
Minia Oncology Center
Minya, Egypt
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.
Time frame: 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.
Time frame: at baseline, at the end of 4 weeks and at the end of 8 weeks
Changes in serum levels of biomarker namely nerve growth factor (NGF).
measuring serum level of nerve growth factor using enzyme-linked immunoassay (ELISA) Kit.
Time frame: at baseline and at end of 8 weeks
Adverse effects of using trimetazidine in preventing Paclitaxel Induced Peripheral Neuropathy.
any adverse/ side effect will be evaluated.
Time frame: 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."
Time frame: at baseline, at the end of 4 weeks and at the end of 8 weeks
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