Ethical committee approval will be obtained from ethics committee of Faculty of Pharmacy, Damanhur University.~2. All participants should agree to take part in this clinical study and will provide informed consent.~3. fifty female patients with diagnosed breast cancer, who are candidates for will be recruited from Damanhur oncology center.~4. All enrolled patients will be randomly assigned into two arms: Group 1 ( Arm A) (n=25: will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week.~Group 2 ( Arm B) (n=25): will receive the same regimen as group1 in addition to 160mg (17 ,18 ) fenofibrate once daily for 3 month.~5. All patients will be submitted to:~Full patient history and clinical examination.~Routine follow up before and after each chemotherapy cycle (complete blood picture, liver function tests, renal function tests).~Serum samples will be collected from patients at the time of admission for measuring the neuropathy biomarkers Nerve growth factor (NGF) and (NFL) to lipid profile .~Clinical assessment of neuropathic pain using FACT/GOG NtX 12 questionnaire and NCT-CTCAE -VERSION-4 .~6. All patients will be followed up during paclitaxel treatment period (12 weeks). At the end of paclitaxel treatment, Serum samples will be collected from patients for measuring the biomarkers .~7. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.~8. Results, conclusion, discussion, and recommendations will be given.
The aim of the study is to assess the efficacy of fenofibrate in either reversing and/or preventing the development of PIPN in breast cancer patients treated with paclitaxel-based regimen. The primary outcome :clinical improvement of neuropathic pain and grade by 1-CT-CTCAE -VERSION-4 & FACT/GOG-NT-12 questionnaire and its effect on quality of life (QOL).~The secondary outcome : the efficacy of fenofibrate in either reversing and/or preventing the development of PIPN via alteration of either Nerve growth factor (NGF) or/ and/( NFL).