Fenofibrate Role in Breast Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fenofibrate Role Against Chemotherapy Induced Peripheral Neurotoxicity in Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Placebo
* Drug: Fenofibrate 160mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>n=25: will receive Placebo plus four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week. | Drug: Placebo<br>* 25 patients will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week<br>* Other names: Placebo tablet;|
| Active Comparator: fenofibrate group<br>n=25: will receive fenofibrate 160mg once daily for 3 month plus four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week. . | Drug: Fenofibrate 160mg<br>* 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.<br>* Other names: Lipanthyl 16omg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve growth factor (NGF) Concentration | Concentration of Nerve growth factor (NGF) | 3 month | 
| Neurofilament light chain (NfL) protein Concentration | Concentration of Neurofilament light chain (NfL) protein | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of neuropathic pain | neuropathic pain using score from FACT/GOG NtX 12 questionnaire . | 6 months |