Fenofibrate Role in Breast Cancer Patients

July 5, 2025 updated by: Rehab Werida, Damanhour University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elbehairah
      • Damanhūr, Elbehairah, Egypt, 31527
        • Damanhour Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
n=25: will receive Placebo plus four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week.
Drug: Placebo
25 patients will receive four cycle of AC followed by paclitaxel 80 mg/m2 weekly for 12 week
Other Names:
  • Placebo tablet
Active Comparator: 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.

.
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.
Other Names:
  • Lipanthyl 16omg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nerve growth factor (NGF) Concentration
Time Frame: 3 month
Concentration of Nerve growth factor (NGF)
3 month
Neurofilament light chain (NfL) protein Concentration
Time Frame: 3 month
Concentration of Neurofilament light chain (NfL) protein
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of neuropathic pain
Time Frame: 6 months
neuropathic pain using score from FACT/GOG NtX 12 questionnaire .
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Study Director: Noha El bassiouny, Lecturer, Damanhour University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 5, 2024

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

April 1, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 5, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fenofibrate in Breast Cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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