Breast Cancer Clinical Trial
Official title:
Fenofibrate Role Against Chemotherapy Induced Peripheral Neurotoxicity in Breast Cancer Patients
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).
Status | Recruiting |
Enrollment | 50 |
Est. completion date | February 1, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion criteria: 1. included a diagnosis breast cancer with age > 18 years. 2. Naïve to chemotherapy Exclusion Criteria: 1. Concurrent administration (statins , cyclosporine) . 2. 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. 3. Patients with a history of allergy to fenofibrate. 4. Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication. 5. Pregnancy or breast feeding. |
Country | Name | City | State |
---|---|---|---|
Egypt | Damanhour Oncology Center | Damanhur | Elbehairah |
Lead Sponsor | Collaborator |
---|---|
Damanhour University |
Egypt,
Caillaud M, Patel NH, White A, Wood M, Contreras KM, Toma W, Alkhlaif Y, Roberts JL, Tran TH, Jackson AB, Poklis J, Gewirtz DA, Damaj MI. Targeting Peroxisome Proliferator-Activated Receptor-alpha (PPAR- alpha) to reduce paclitaxel-induced peripheral neuropathy. Brain Behav Immun. 2021 Mar;93:172-185. doi: 10.1016/j.bbi.2021.01.004. Epub 2021 Jan 9. — View Citation
Othman A, Benghozi R, Alecu I, Wei Y, Niesor E, von Eckardstein A, Hornemann T. Fenofibrate lowers atypical sphingolipids in plasma of dyslipidemic patients: A novel approach for treating diabetic neuropathy? J Clin Lipidol. 2015 Jul-Aug;9(4):568-75. doi: 10.1016/j.jacl.2015.03.011. Epub 2015 Apr 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nerve growth factor (NGF) Concentration | Concentration of Nerve growth factor (NGF) | 3 month | |
Primary | Neurofilament light chain (NfL) protein Concentration | Concentration of Neurofilament light chain (NfL) protein | 3 month | |
Secondary | Incidence of neuropathic pain | neuropathic pain using score from FACT/GOG NtX 12 questionnaire . | 6 months |
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