drugset / Trial / NCT06553157
Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy
RandomizedParallel-groupOpen-labelPrevention
Summary
Platinum based chemotherapy (mainly Cisplatin) is known to cause a variety of adverse effects, including Ototoxicity and nephrotoxicity. Ototoxicity is estimated to affect about 36% of adult patients treated with cisplatin, many therapeutic interventions have been studied to reduce the risk of developing ototoxicity from Cisplatin treatment, Statins have been studied in animals and have shown promising results, this study is aimed to explore the effect of statins on the incidence of ototoxicity in humans.
Timeline
- Start
- 2024-09-01
- Primary completion
- 2025-07-01
- Completion
- 2025-10-01
Publications
- Background Fernandez K, Spielbauer KK, Rusheen A, Wang L, Baker TG, Eyles S, Cunningham LL. Lovastatin protects against cisplatin-induced hearing loss in mice. Hear Res. 2020 Apr;389:107905. doi: 10.1016/j.heares.2020.107905. Epub 2020 Feb 6.
- Background Fernandez KA, Allen P, Campbell M, Page B, Townes T, Li CM, Cheng H, Garrett J, Mulquin M, Clements A, Mulford D, Ortiz C, Brewer C, Dubno JR, Newlands S, Schmitt NC, Cunningham LL. Atorvastatin is associated with reduced cisplatin-induced hearing loss. J Clin Invest. 2021 Jan 4;131(1):e142616. doi: 10.1172/JCI142616.
- Background Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL, Nondahl DM. The impact of hearing loss on quality of life in older adults. Gerontologist. 2003 Oct;43(5):661-8. doi: 10.1093/geront/43.5.661.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | — | — |
| Subject | Fluvastatin | Other / unclassified | — | — |
| Subject | Lovastatin | Small molecule | — | — |
| Subject | Pitavastatin | Small molecule | — | — |
| Subject | Pravastatin | Small molecule | — | — |
| Subject | Rosuvastatin | Small molecule | — | — |
| Subject | Simvastatin | Small molecule | — | — |