Actively Recruiting
Phase II Study of Atorvastatin to Reduce Hearing Loss Caused by Cisplatin in Head and Neck Cancer
Led by National Institute on Deafness and Other Communication Disorders (NIDCD) · Updated on 2026-06-05
224
Participants Needed
5
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether atorvastatin, a drug commonly used to lower cholesterol, can reduce the risk of hearing loss caused by cisplatin chemotherapy in people with head and neck squamous cell carcinoma. This study focuses on individuals aged 18 and older who are undergoing treatment with cisplatin-based chemotherapy combined with radiation therapy. The study aims to compare hearing changes in patients taking atorvastatin versus a placebo to better understand its potential protective effects. Participants will be divided into two groups: those already taking statin medications will join an observational arm, while those not on statins will be randomly assigned to receive either 40 mg of atorvastatin or a placebo daily. The medication or placebo will be taken by mouth or feeding tube during cisplatin treatment and for three months afterward. Study visits include hearing evaluations before treatment starts, within three months after treatment, and within two years after treatment, along with blood tests at consent and 12 weeks later. During the study, participants will undergo hearing tests using headphones and tympanograms that assess ear drum mobility. They will also complete questionnaires related to hearing at each visit. Researchers will monitor hearing loss based on specific criteria and track overall and disease-free survival up to two years after chemotherapy. Long-term follow-up includes reviewing medical records two years after treatment to assess outcomes and safety.
CONDITIONS
Brief 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...
- Willingness and ability to comply with all study procedures and be available for the study duration
- Ability to provide informed consent
- Adults aged 18 years or older
- Diagnosed with squamous cell carcinoma of the head and neck and planned treatment with cisplatin-based chemotherapy and radiation
- Hearing thresholds at or better than 70 dB HL at 1, 2, and 4 kHz in at least one ear at baseline
- Baseline lab values under 1.5 times the upper limit of normal for AST, ALT, creatine phosphokinase, and creatinine
- Ability to take oral medication by mouth or feeding tube and willingness to follow daily atorvastatin or placebo regimen
- For females of reproductive potential, use of highly effective contraception before and during the study plus 8 weeks after treatment
You will not qualify if you...
- Currently taking a statin drug
- Bilateral flat, Type B tympanogram
- Bilateral cochlear implants
- Pre-existing liver or kidney disease interfering with atorvastatin use
- Prior treatment with cisplatin chemotherapy
- Staff members of the NIDCD sections or lead site investigators
- Under 18 years of age
- Current use of certain interacting medications such as cimetidine, spironolactone, ketoconazole, cyclosporine, protease inhibitors, gemfibrozil, clarithromycin, or itraconazole
- Pregnancy, lactation, or plans to become pregnant
- Known allergy to atorvastatin or placebo components
- Other severe or unstable medical conditions increasing safety risk
- Expected use of aminoglycoside antibiotics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 to 4 months (duration of cisplatin-based chemotherapy)
Participants take atorvastatin (40 mg) or placebo daily by mouth or feeding tube while undergoing cisplatin-based chemotherapy for head and neck cancer. Hearing sensitivity and adverse events are monitored during this period.
Regular visits during chemotherapy as per treatment schedule
Duration - Up to 2 years post-chemotherapy
Participants undergo hearing assessments and monitoring for adverse events up to 12 weeks after completing chemotherapy. Long-term survival and disease-free status are assessed up to 2 years after treatment.
Visits at 12 ± 4 weeks post-chemotherapy and at 3 months, 1 year, and 2 years for survival assessments
Trial Site Locations
Total: 5 locations
1
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively 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
Actively Recruiting
5
Inova Schar Cancer Center
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
K
Katharine A Fernandez, Au.D.
L
Lisa L Cunningham, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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