Clinical trial NCT05813145: Fenofibrate Role in Breast Cancer Patients
Official title: Fenofibrate Role Against Chemotherapy Induced Peripheral Neurotoxicity in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nerve growth factor (NGF) Concentration
timeFrame: 3 month
measure: Neurofilament light chain (NfL) protein Concentration
timeFrame: 3 month
Secondary outcomes:
measure: Incidence of neuropathic pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Oncology Center
state: Elbehairah
Study officials:
affiliation: Damanhour University
name: Noha El bassiouny, Lecturer
role: STUDY_DIRECTOR
References:
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.
citation: 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.