RecruitingPhase 2NCT04915183

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

Phase II Interventional Study Using Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer


Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Enrollment

224 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether atorvastatin (a cholesterol-lowering drug commonly used for heart health) can protect hearing in people with head and neck cancer who are being treated with cisplatin chemotherapy, which is known to cause hearing loss. **You may be eligible if:** - You are 18 or older and have been diagnosed with squamous cell carcinoma of the head and neck - You are scheduled to receive cisplatin chemotherapy with radiation (with or without immunotherapy) - You currently have usable hearing in at least one ear - Your liver, kidney, and muscle enzyme levels are within normal range - You are able to swallow pills or take medication through a feeding tube **You may NOT be eligible if:** - You are already taking a statin medication - You have previously been treated with platinum-based chemotherapy - You have pre-existing serious liver or kidney disease - You have cochlear implants in both ears - You are pregnant, breastfeeding, or planning to become pregnant - You take certain medications that interact with atorvastatin (such as cyclosporine, ketoconazole, or clarithromycin) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPlacebo

Placebo will be formulated to also contain a white powder such that the atorvastatin and placebo are indistinguishable even if a capsule is opened.

DRUGAtorvastatin

Subjects will be provided with atorvastatin (40 mg) or placebo to be taken daily by mouth or by feeding tube. The tablets may be taken whole or crushed according to patient swallowing capabilities and preference.


Locations(5)

Winship Cancer Institute at Emory University

Atlanta, Georgia, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor

Rochester, New York, United States

Inova Schar Cancer Center

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT04915183


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