Fenofibrate Role Against Chemotherapy Induced Peripheral Neurotoxicity in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Nerve growth factor (NGF) Concentration
研究概览
简要总结
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).
详细描述
Ethical committee approval will be obtained from ethics committee of Faculty of Pharmacy, Damanhur University.
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All participants should agree to take part in this clinical study and will provide informed consent.
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fifty female patients with diagnosed breast cancer, who are candidates for will be recruited from Damanhur oncology center.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
Placebo Group
n=25: will receive Placebo plus four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week.
干预措施: Placebo (Drug)
fenofibrate group
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.
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干预措施: Fenofibrate 160mg (Drug)
结局指标
主要结局
Nerve growth factor (NGF) Concentration
时间窗: 3 month
Concentration of Nerve growth factor (NGF)
Neurofilament light chain (NfL) protein Concentration
时间窗: 3 month
Concentration of Neurofilament light chain (NfL) protein
次要结局
- Incidence of neuropathic pain(6 months)
研究者
Rehab Werida
Principal Investigator
Damanhour University