Fenofibrate Role in Breast Cancer Patients

Last updated: July 5, 2025
Sponsor: Damanhour University
Overall Status: Completed

Phase

N/A

Condition

Cancer

Breast Cancer

Treatment

Fenofibrate 160mg

Placebo

Clinical Study ID

NCT05813145
Fenofibrate in Breast Cancer
  • Ages 18-60
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. included a diagnosis breast cancer with age > 18 years.

  2. Naïve to chemotherapy

Exclusion

Exclusion Criteria:

  1. Concurrent administration (statins , cyclosporine) .

  2. Advanced liver disease (defined as liver enzyme elevation >3-fold upper limit ofnormality, or cirrhosis); chronic kidney disease (CKD, defined as an eGFR <60 mlmin-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, otherneuropathic pain medication.

  5. Pregnancy or breast feeding.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Fenofibrate 160mg
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
August 05, 2024

Study Description

Ethical committee approval will be obtained from ethics committee of Faculty of Pharmacy, Damanhur University.

  1. All participants should agree to take part in this clinical study and will provide informed consent.

  2. fifty female patients with diagnosed breast cancer, who are candidates for will be recruited from Damanhur oncology center.

  3. 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.

  1. 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 .

    1. 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 .

    2. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.

    3. Results, conclusion, discussion, and recommendations will be given.

Connect with a study center

  • Damanhour Oncology Center

    Damanhūr, Elbehairah 31527
    Egypt

    Site Not Available

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