Fenofibrate Role in Breast Cancer Patients

NCT05813145 | Completed DMC

• 1 other identifier: Fenofibrate in Breast Cancer
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of neuropathic pain

  6 months

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

fenofibrate group

ACTIVE COMPARATOR

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

Interventions

Placebo DRUG

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

Also known as: Placebo tablet

Placebo Group

Fenofibrate 160mg 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.

Also known as: Lipanthyl 16omg

fenofibrate group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• included a diagnosis breast cancer with age \> 18 years.
• Naïve to chemotherapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Damanhour Oncology Center

Damanhūr, Elbehairah, 31527, Egypt

Location

Related Publications (2)

• 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.

  PMID: 26228675 BACKGROUND

• 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.

  PMID: 33434562 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Officials

• Noha El bassiouny, Lecturer

  Damanhour University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 14, 2023
• Study Start: January 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 5, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)