Fenofibrate Role in Breast Cancer Patients

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05813145
Study type	Interventional
Source	Damanhour University
Contact	Rehab H Werida, Ass. Prof.
Phone	+201005359968
Email	rehabwrieda@pharm.dmu.edu.eg
Status	Recruiting
Phase	N/A
Start date	January 1, 2023
Completion date	February 1, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.