Clinical trial · Interventional
Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy
Evaluation of the Effect of Statins on the Incidence of Side Effects of Platinum Based Chemotherapy in Patients With Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ototoxicity | — | UNRESOLVED | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Statin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control group
- description
- no intervention
- type
- EXPERIMENTAL
- label
- intervention group
- description
- study drug once daily for treatment period
- interventionNames
- Drug: Statin
Primary outcomes (2)
- measure
- change in hearing as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) using Audiometry as a tool
- timeFrame
- 3 months after end of treatment
- description
- grade 1:Adults enrolled on a Monitoring Program (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear. grade 2: enrolled on a Monitoring Program (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift of \>25 dB averaged at 2 contiguous test frequencies in at least one ear. grade 3: enrolled on a Monitoring Program (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift of \>25 dB averaged at 3 contiguous test frequencies in at least one ear; therapeutic intervention indicated. grade 4: Decrease in hearing to profound bilateral loss (absolute threshold \>80 dB HL at 2 kHz and above); nonservicable hearing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients will receive platinum based chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2. Exclusion Criteria: * Pregnant or lactating women. * Patients receiving vitamin/ supplementation drugs that interfere with the study intervention. * Patients with contraindications to statins including acute liver failure or decompensated cirrhosis.
References
Publications (3)
- BACKGROUNDFernandez 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. PMID 32062294
- BACKGROUNDFernandez 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. PMID 33393488
- BACKGROUNDDalton 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. PMID 14570962