Effect of statins on side effects from platinum-based chemotherapy
Evaluation of the Effect of Statins on the Incidence of Side Effects of Platinum Based Chemotherapy in Patients With Solid Tumors
This study is testing if taking statins can help reduce hearing problems in patients getting platinum-based chemotherapy, like cisplatin.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Minia and 1 other locations) |
| Trial ID | NCT06553157 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of statins on the incidence of ototoxicity in patients undergoing platinum-based chemotherapy, particularly with cisplatin. Ototoxicity is a significant adverse effect affecting a substantial percentage of patients treated with these agents. The study aims to determine whether statins can reduce the risk of hearing impairment associated with cisplatin treatment. Patients receiving platinum-based chemotherapy will be enrolled, and they will be randomized to receive either statins or a placebo.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who are scheduled to receive platinum-based chemotherapy and have an ECOG performance status of 0 to 2.
Not a fit: Patients who are pregnant, lactating, or have contraindications to statins will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of ototoxicity in patients receiving cisplatin, improving their quality of life.
How similar studies have performed: While statins have shown promise in animal studies for reducing ototoxicity, this approach in humans is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Minia and 1 other locations
- Minia University hospital, department of oncology and nuclear medicine — Minia, Egypt (Recruiting)
- Minia University hospital, department of oncology and nuclear medicine — Minya, Egypt (Not_yet_recruiting)
Study contacts
- Principal investigator: Noha H. Helmy, Masters — Department of Clinical Pharmacy, Faculty of Pharmacy, Minia University
- Study coordinator: Noha H. Mohamed Helmy, Masters
- Email: noha.hassan@mu.edu.eg
- Phone: +20 1023008427
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.