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Fenofibrate Role in Breast Cancer Patients

NCT05813145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-08

No results posted yet for this 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).

Conditions

Interventions

DRUG

Placebo

25 patients will receive 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.

Sponsors & Collaborators

  • Damanhour University

    lead OTHER

Principal Investigators

  • Noha El bassiouny, Lecturer · Damanhour University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-08-01
Completion
2024-08-05

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05813145 on ClinicalTrials.gov