Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Diagnoza raka płaskonabłonkowego głowy i szyi potwierdzona badaniem histopatologicznym
- •Planowane leczenie cisplatyną i radioterapią
- •Zdolność do przyjmowania leku drogą ustną lub przez sondę żołądkową
- •Prawidłowe wyniki wstępnych badań krwi (enzymy wątroby i inne wskaźniki poniżej 1,5x normy)
- •Słuch w przynajmniej jednym uchu nie gorszy niż 70 dB HL na częstotliwościach 1, 2 i 4 kHz
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 100 Years
- Last updated (source)
- September 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (5)
Winship Cancer Institute at Emory University
Atlanta, United States
University of Maryland Medical Center
Baltimore, United States
National Institutes of Health Clinical Center
Bethesda, United States
Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor
Rochester, United States
Inova Schar Cancer Center
Fairfax, United States
Trial contact
Katharine A Fernandez, Au.D.
Lisa L Cunningham, Ph.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/3/2026.
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