Fenofibrate Role in Breast Cancer Patients

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Damanhour University
• Treatments: Fenofibrate

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.