Fenofibrate Role in Breast Cancer Patients

NCT ID: NCT05813145

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-08-05

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo Group

n=25: will receive Placebo plus four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

25 patients will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week

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.

.

Group Type: ACTIVE_COMPARATOR

Fenofibrate 160mg

Intervention Type: DRUG

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.

Interventions

Placebo

25 patients will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week

Intervention Type: DRUG

Fenofibrate 160mg

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.

Intervention Type: DRUG

Other Intervention Names

Placebo tablet; Lipanthyl 16omg

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Werida

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noha El bassiouny, Lecturer

Role: STUDY_DIRECTOR

Damanhour University

Locations

Damanhour Oncology Center

Damanhūr, Elbehairah, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 26228675 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33434562 (View on PubMed)

Other Identifiers

Fenofibrate in Breast Cancer

Identifier Type: -

Identifier Source: org_study_id