Condition: Hearing Loss · Head and Neck Cancer · Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)
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 …
This description comes directly from the study's public registry record.
Katharine A Fernandez, Au.D. · (240) 215-7152 · katharine.fernandez@nih.gov
Lisa L Cunningham, Ph.D. · (301) 443-2766 · cunninghamll@mail.nih.gov
Always discuss trial participation with your own doctor first.
| Winship Cancer Institute at Emory University | Atlanta, Georgia, United States | Recruiting |
| University of Maryland Medical Center | Baltimore, Maryland, United States | Recruiting |
| National Institutes of Health Clinical Center | Bethesda, Maryland, United States | Recruiting |
| Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor | Rochester, New York, United States | Recruiting |
| Inova Schar Cancer Center | Fairfax, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04915183