Phase 2 Hearing Loss Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are willing and able to follow all study procedures and can commit to the full length of the study
- You are able to understand and sign a consent form agreeing to take part
- You are 18 years of age or older
- You have been diagnosed with squamous cell carcinoma of the head and neck (a specific type of head and neck cancer), confirmed by a tissue sample, and you are planned to receive cisplatin-based chemotherapy alongside radiation therapy aimed at curing the cancer, or chemotherapy before surgery — including patients also receiving immunotherapy alongside cisplatin
- You have sufficient hearing in at least one ear at the time of your baseline hearing test (specific hearing levels will be checked by the study team)
- Your recent blood test results for liver enzymes, a muscle enzyme, and kidney function are within an acceptable range (the study team will check these)
- You are able to swallow a tablet by mouth or take it through a feeding tube, and you are willing to take a daily atorvastatin or placebo pill as instructed
- If you are a woman who could become pregnant, you have been using highly effective birth control for at least one month before joining, and agree to continue using it during the study and for 8 weeks after finishing the study medication
Who may not be able to join:
- You are currently taking any statin medication (a type of cholesterol-lowering drug)
- You have a specific type of hearing test result in both ears that suggests a middle ear problem (confirm with trial site)
- You have cochlear implants in both ears
- You have existing liver or kidney disease that the study doctor believes would make it unsafe for you to take the study medication
- You have previously been treated with cisplatin chemotherapy
- You are a member of staff at the study institutions leading this trial
- You are under 18 years old
- You are currently taking certain medications including cimetidine, spironolactone, ketoconazole, cyclosporine, protease inhibitors, gemfibrozil, clarithromycin, or itraconazole
- You are pregnant, breastfeeding, or planning to become pregnant
- You have a known allergy to any ingredient in atorvastatin or the placebo
- You have another serious or unstable health condition that the study doctor believes could put you at risk or prevent you from completing the study
- You are expected to need aminoglycoside antibiotics (a specific type of antibiotic) during the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Lisa L Cunningham, Ph.D., National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: (240) 215-7152
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
To determine the effectiveness of atorvastatin (20 mg) at reducing the incidence and severity of cisplatin-induced hearing loss in patients with head and neck squamous cell carcinoma (HNSCC).
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.