Peripheral Neuropathy Due to Chemotherapy
Conditions
Keywords
Paclitaxel, Trimetazidine, quality of life, nerve growth factor, peripheral neuropathy
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.
Interventions
DRUGTrimetazidine
Trimetazidine 35 mg tab once daily
DRUGPlacebo
Placebo once daily
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria | 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. |
| Patient's Quality of Life | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum levels of biomarker namely nerve growth factor (NGF). | at baseline and at end of 8 weeks | measuring serum level of nerve growth factor using enzyme-linked immunoassay (ELISA) Kit. |
| Adverse effects of using trimetazidine in preventing Paclitaxel Induced Peripheral Neuropathy. | at baseline and weekly up to 8 week | any adverse/ side effect will be evaluated. |
| Severity of chemotherapy induced-peripheral neuropathy. | 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. |
Countries
Egypt
Outcome results
None listed