Fenofibrate Role in Breast Cancer Patients

Ethical committee approval will be obtained from ethics committee of Faculty of Pharmacy, Damanhur University.

• All participants should agree to take part in this clinical study and will provide informed consent.

• fifty female patients with diagnosed breast cancer, who are candidates for will be recruited from Damanhur oncology center.

• 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.

• 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 .

• 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 .

• Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.

• Results, conclusion, discussion, and recommendations will be given.

Inclusion criteria

• included a diagnosis breast cancer with age > 18 years.
• Naïve to chemotherapy

Exclusion criteria

• Concurrent administration (statins , cyclosporine) .
• Advanced liver disease (defined as liver enzyme elevation >3-fold upper limit of normality, or cirrhosis); chronic kidney disease (CKD, defined as an eGFR <60 ml min-1 1.73 m-2); acute or chronic pancreatitis and diabetes.
• Patients with a history of allergy to fenofibrate.
• Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication.
• Pregnancy or breast feeding.