Actively Recruiting
Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
Led by National Institute on Deafness and Other Communication Disorders (NIDCD) · Updated on 2026-03-09
224
Participants Needed
5
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to follow all study procedures and available for the entire study duration
- Able to provide signed informed consent
- Adult aged 18 years or older
- Diagnosed with squamous cell carcinoma of the head and neck confirmed by pathology
- Planned treatment with cisplatin-based chemotherapy and radiation with curative intent or neoadjuvant chemotherapy
- Radiation planned with dose to cochlea less than 35 Gy
- Hearing thresholds of 70 dB HL or better at 1, 2, and 4 kHz in at least one ear at baseline
- Baseline lab tests within 1.5 times upper normal limits for AST, ALT, creatine phosphokinase, and creatinine
- Able to take oral medication or feeding tube and willing to follow daily atorvastatin or placebo regimen
- For females of reproductive potential, using highly effective contraception for at least 1 month before enrollment and during study plus 8 weeks after drug administration
You will not qualify if you...
- Currently taking any statin drug
- Bilateral flat, Type B tympanogram
- Bilateral cochlear implants
- Pre-existing liver or kidney disease that may interfere with atorvastatin use
- Prior treatment with platinum chemotherapy drugs
- Staff members of the NIDCD Sections or lead site investigators
- Children under 18 years
- Current use of cimetidine, spironolactone, ketoconazole, cyclosporine, protease inhibitors, gemfibrozil, clarithromycin, or itraconazole
- Pregnancy, breastfeeding, or planning pregnancy
- Known allergy to atorvastatin or placebo components
- Other severe or unstable medical conditions increasing safety risk or preventing study completion
- Expected use of aminoglycoside antibiotics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
3
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
4
Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor
Rochester, New York, United States, 14642
Not Yet Recruiting
5
Inova Schar Cancer Center
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
K
Katharine A Fernandez, Au.D.
CONTACT
L
Lisa L Cunningham, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here