Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck
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 cispl
| Condition(s) | Hearing Loss, Head and Neck Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | * INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria evaluated by the study team, including an on-site oncologist: * Willingness and ability to comply with and participate in all study procedures and availability for the duration of the study * Ability to provide consent and provision of signed and dated informed consent form * Adult subjects, aged \>=18 * Diagnosed with squamous cell carcinoma of the head and neck, confirmed by a pathologic review of surgical or biopsy specimen(s), who meet standard clinical and laboratory criteria and will undergo treatment with concomitant cisplatin-based chemotherapy and radiation with curative intent or treatment with neoadjuvant chemotherapy (NAC). This includes subjects who |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Lead sponsor | National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Locations | Atlanta, Georgia, United States; Baltimore, Maryland, United States; Bethesda, Maryland, United States; Rochester, New York, United States; Fairfax, Virginia, United States |
| Start date | 2024-07-10 |
| NCT ID | NCT04915183 |
| Official listing | https://clinicaltrials.gov/study/NCT04915183 |