Clinical Study to Evaluate the Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Sponsor study identifier
interventional
44
1 country
1
Study Start
December 1, 2023
Actual (reported)Primary Completion
January 1, 2025
Actual (reported)Study Completion
January 1, 2025
Actual (reported)This study aims at evaluating the possible safety and efficacy of fenofibrate in attenuating doxorubicin related cardiac toxicity in breast cancer patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 19, 2023
Actual (reported)December 1, 2023
Actual (reported)December 4, 2023
Actual (reported)January 1, 2025
Actual (reported)January 1, 2025
Actual (reported)Assessment of changes in ejection fraction (the amount of blood that heart pumps each beat) using echocardiography
The primary outcome is to avoid decrease in patients ejection fraction while administrating doxorubicin which is known to cause a declination in cardiac ejection fraction threatening of heart failure
3 months
Changes in serum levels of the measured biological markers
3 months
22 patients which will receive four cycles of AC regimen (doxorubicin and cyclophosphamide; each cycle is given every 21 day) plus placebo tablets once daily.
22 patients which will receive four cycles of AC regimen (doxorubicin and cyclophosphamide; each cycle is given every 21 day) plus Fenofibrate 160 mg once daily.
It is an approved drug for hypercholesterolemia, It lowers lipid levels by activating peroxisome proliferator-activated receptor alpha (PPARα).
Placebo is made to look exactly like a real drug but is made of an inactive substance.
Hagar Dewidar
Tanta, Elgharbya, 31527, Egypt
Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.
Cardinale D, Iacopo F, Cipolla CM. Cardiotoxicity of Anthracyclines. Front Cardiovasc Med. 2020 Mar 18;7:26. doi: 10.3389/fcvm.2020.00026. eCollection 2020.
Hagar Dewidar, Instructor
Tanta University
44 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2023
First Posted
December 4, 2023
Study Start
December 1, 2023
Actual (reported)Anthracycline derived chemotherapy used in treatment of breast cancer
Alkylating agent used in treatment of breast cancer
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Czupryniak L, Joshi SR, Gogtay JA, Lopez M. Effect of micronized fenofibrate on microvascular complications of type 2 diabetes: a systematic review. Expert Opin Pharmacother. 2016 Aug;17(11):1463-73. doi: 10.1080/14656566.2016.1195811. Epub 2016 Jun 15.
Huang WP, Yin WH, Chen JS, Huang PH, Chen JW, Lin SJ. Fenofibrate attenuates doxorubicin-induced cardiac dysfunction in mice via activating the eNOS/EPC pathway. Sci Rep. 2021 Jan 13;11(1):1159. doi: 10.1038/s41598-021-80984-4.
Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
Jen HL, Liu PL, Chen YH, Yin WH, Chen JW, Lin SJ. Peroxisome Proliferator-Activated Receptor alpha Reduces Endothelin-1-Caused Cardiomyocyte Hypertrophy by Inhibiting Nuclear Factor-kappaB and Adiponectin. Mediators Inflamm. 2016;2016:5609121. doi: 10.1155/2016/5609121. Epub 2016 Oct 11.
Kim NH, Kim SG. Fibrates Revisited: Potential Role in Cardiovascular Risk Reduction. Diabetes Metab J. 2020 Apr;44(2):213-221. doi: 10.4093/dmj.2020.0001.
Rawat PS, Jaiswal A, Khurana A, Bhatti JS, Navik U. Doxorubicin-induced cardiotoxicity: An update on the molecular mechanism and novel therapeutic strategies for effective management. Biomed Pharmacother. 2021 Jul;139:111708. doi: 10.1016/j.biopha.2021.111708. Epub 2021 May 13.
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Walker AE, Kaplon RE, Lucking SM, Russell-Nowlan MJ, Eckel RH, Seals DR. Fenofibrate improves vascular endothelial function by reducing oxidative stress while increasing endothelial nitric oxide synthase in healthy normolipidemic older adults. Hypertension. 2012 Dec;60(6):1517-23. doi: 10.1161/HYPERTENSIONAHA.112.203661. Epub 2012 Oct 29.
Dewidar HK, Ghannam AA, Mostafa TM. Fenofibrate attenuates doxorubicin-induced cardiotoxicity in patients with breast cancer: a randomized controlled trial. Naunyn Schmiedebergs Arch Pharmacol. 2025 Dec;398(12):17109-17119. doi: 10.1007/s00210-025-04326-1. Epub 2025 Jun 3.
Primary Completion
January 1, 2025
Actual (reported)Study Completion
January 1, 2025
Actual (reported)Last Updated
August 19, 2025
Record last verified: 2025-08
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