Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Hearing Loss, Head and Neck Cancer

In brief

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.

Key facts

Study ID: NCT04915183
Run by: National Institute on Deafness and Other Communication Disorders (NIDCD)
People needed: 224
Starts: 2024-07-10
Expected to finish: 2030-08-31
Last updated by the study team: 2026-06-05

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

An individual who meets any of the following criteria will be excluded from participation in this study:
Subjects currently taking a statin drug
Subjects with bilateral flat, Type B tympanogram
Subjects with bilateral cochlear implants
Pre-existing liver or kidney disease that in the opinion of the investigator would interfere with taking Atorvastatin 40 mg daily.
Subjects with a history of prior treatment with cisplatin chemotherapy
Staff members of the NIDCD Sections and of the lead site investigators headed by the PIs
Children will be excluded because HNSCC in children under age 18 is exceedingly rare
Current use of cimetidine, spironolactone, ketoconazole, cyclosporine, protease inhibitors, gemfibrozil, clarithromycin or itraconazole
Pregnancy, lactation, or plan to become pregnant
Known allergic reactions to components of atorvastatin or the placebo
Other severe or unstable medical conditions which clinical site PI believes increase risk to safety or ability to complete study
Expected concomitant use of aminoglycoside antibiotics

Where it is running

Winship Cancer Institute at Emory University — Atlanta, Georgia, United States (enrolling)
University of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)
National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor — Rochester, New York, United States (enrolling)
Inova Schar Cancer Center — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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