Evaluation of the Effect of Rosuvastatin on Cisplatin-induced Nephrotoxicity and Ototoxicity
NCT ID: NCT04817904
Last Updated: 2021-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
65 participants
INTERVENTIONAL
2020-11-17
2021-08-31
Brief Summary
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Cisplatin nephrotoxicity occurs through several mechanisms, mainly through the transport and accumulation of cisplatin into renal epithelial cells, injury to nuclear and mitochondrial DNA, activation of multiple cell death pathways and initiation of inflammatory response. Accordingly, several experimental strategies were developed to prevent this toxicity. For example, drugs that reduced renal cisplatin accumulation such as organic cation transporter 2 (OCT2) and copper transporter (Ctr1) inhibitors, antioxidants, antiapoptotic and anti-inflammatory agents were investigated. However, many of these drugs interfered with the cytotoxic effects of cisplatin.
Statins are agents used for reducing plasma cholesterol through the inhibition of the enzyme 3- hydroxy-3- methylglutaryl coenzyme A (HMG-CoA) reductase. In addition, statins are also proven to have pleiotropic, non-lipid dependent effects. These effects include anti-inflammatory actions and reduction of oxidative stress. Based on animal studies performed, statins have been shown to reduce the nephrotoxic effects of cisplatin in rats. In addition, ongoing clinical trials are aiming to investigate the role of statins in the protection against the ototoxicity of cisplatin as well. Our aim is to assess the protective effect of statins on cisplatin-induced nephrotoxicity and ototoxicity in humans.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Statin-Treated
This arm will be receiving:
* Cisplatin along with conventional nephroprotective interventions (IV hydration with 3 liters with electrolyte replacement administered on the same day of cisplatin)
* Rosuvastatin 10 mg/day
Rosuvastatin 10mg
The statin-treated arm will receive Rosuvastatin tablets 10 mg/day starting from the point of cisplatin initiation through the entire duration of therapy
Statin-Free
This arm will be receiving:
-Cisplatin along with conventional nephroprotective interventions only (IV hydration with 3 liters with electrolyte replacement administered on the same day of cisplatin)
No interventions assigned to this group
Interventions
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Rosuvastatin 10mg
The statin-treated arm will receive Rosuvastatin tablets 10 mg/day starting from the point of cisplatin initiation through the entire duration of therapy
Eligibility Criteria
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Inclusion Criteria
* Normal baseline serum creatinine levels
* Normal baseline audiometry
* Age between 18-70 years
Exclusion Criteria
* Patients with prior chemotherapy treatment
* Treatment with statins within 12 months before assignment
* Treatment with fibrates within 4 weeks before assignment
* Pregnancy and Lactation
* Abnormal liver function tests or blood count
18 Years
70 Years
ALL
No
Sponsors
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German University in Cairo
OTHER
Cairo University
OTHER
Responsible Party
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Aya Tarek Moustafa
Principal Investigator
Principal Investigators
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Mohamed H Solayman, PhD
Role: STUDY_CHAIR
German University in Cairo
Loay Kassem, PhD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Dalia S Elhelw, PhD
Role: PRINCIPAL_INVESTIGATOR
German University in Cairo
Aya T Moustafa, BSc
Role: PRINCIPAL_INVESTIGATOR
German University in Cairo
Locations
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Kasr El-Aini Center of Radiation Oncology and Nuclear Medicine
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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An Y, Xin H, Yan W, Zhou X. Amelioration of cisplatin-induced nephrotoxicity by pravastatin in mice. Exp Toxicol Pathol. 2011 Mar;63(3):215-9. doi: 10.1016/j.etp.2009.12.002. Epub 2010 Jan 8.
Fujieda M, Morita T, Naruse K, Hayashi Y, Ishihara M, Yokoyama T, Toma T, Ohta K, Wakiguchi H. Effect of pravastatin on cisplatin-induced nephrotoxicity in rats. Hum Exp Toxicol. 2011 Jul;30(7):603-15. doi: 10.1177/0960327110376551. Epub 2010 Jul 22.
Seckl MJ, Ottensmeier CH, Cullen M, Schmid P, Ngai Y, Muthukumar D, Thompson J, Harden S, Middleton G, Fife KM, Crosse B, Taylor P, Nash S, Hackshaw A. Multicenter, Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Pravastatin Added to First-Line Standard Chemotherapy in Small-Cell Lung Cancer (LUNGSTAR). J Clin Oncol. 2017 May 10;35(14):1506-1514. doi: 10.1200/JCO.2016.69.7391. Epub 2017 Feb 27.
Pabla N, Dong Z. Cisplatin nephrotoxicity: mechanisms and renoprotective strategies. Kidney Int. 2008 May;73(9):994-1007. doi: 10.1038/sj.ki.5002786. Epub 2008 Feb 13.
Other Identifiers
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S-4-2020
Identifier Type: -
Identifier Source: org_study_id
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