OncoMatch/Clinical Trials/NCT04915183
Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
Is NCT04915183 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Atorvastatin for hearing loss.
Treatment: Atorvastatin — Background: Cisplatin is used to treat head and neck cancer. People who take this drug are at risk for hearing loss. Atorvastatin is a drug used to treat high cholesterol. It might reduce the risk of cisplatin-induced hearing loss. Objective: To find out if atorvastatin reduces hearing loss in people treated with cisplatin and radiation. Eligibility: People ages 18 and older with squamous cell carcinoma of the head and neck who will undergo treatment with cisplatin-based chemotherapy and radiation Design: Participants will be screened with their medical records. Participants currently taking a cholesterol-lowering statin medication are invited to participate in the observational arm of the study. Those not taking such a medication are invited to participate in the interventional arm of the study. All participants will have 3 study visits for the purpose of evaluating hearing. One before starting cisplatin treatment, one within 3 months of completing cancer treatment, and one within 2 years of completing cancer treatment. They will have tympanograms. A small flexible tip will be placed in the ear canal. A puff of air will be delivered to assess mobility of the ear drum. They will have hearing tests. They will wear headphones. They will listen to tones that vary in loudness. They will be asked to indicate when they hear a sound. They will complete 3 questionnaires at the time of each hearing test. Participants will have 2 visits for blood tests. These will occur upon consent and 12 weeks after. They will be randomly assigned to take the study drug or placebo orally, once daily. They will take it during cisplatin treatment and for 3 months after treatment. Long-term follow up will include a chart review 2 years after participants complete their cisplatin therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Prior therapy
Cannot have received: platinum chemotherapy
Subjects with a history of prior treatment with platinum chemotherapy drugs
Lab requirements
Kidney function
creatinine <1.5x uln
Liver function
ast/alt <1.5x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Winship Cancer Institute at Emory University · Atlanta, Georgia
- University of Maryland Medical Center · Baltimore, Maryland
- National Institutes of Health Clinical Center · Bethesda, Maryland
- Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor · Rochester, New York
- Inova Schar Cancer Center · Fairfax, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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