NCT05813145

Fenofibrate Role in Breast Cancer Patients

Fenofibrate Role Against Chemotherapy Induced Peripheral Neurotoxicity in Breast Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Placebo	25 patients will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week
DRUG	Fenofibrate 160mg	25 patients will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week in addition to 160mg fenofibrate once daily for 3 month.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-08-01
• Completion: 2024-08-05
• First posted: 2023-04-14
• Last updated: 2025-07-08

Locations

1 site across 1 country: Egypt