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Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
NCT04915183 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Atorvastatin
Study Locations (5)
Maryland
- University of Maryland Medical Center — Baltimore
- National Institutes of Health Clinical Center — Bethesda
Georgia
- Winship Cancer Institute at Emory University — Atlanta
New York
- Wilmot Cancer Institute at the University of Rochester Medical Center in New Yor — Rochester
Virginia
- Inova Schar Cancer Center — Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2024-07-10 |
| Est. Completion | 2030-08-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04915183
The ClinicalTrials.gov registry entry for NCT04915183 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Deafness and Other Communication Disorders (NIDCD), which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04915183 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Maryland, Georgia, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04915183 about?
NCT04915183 is a clinical study titled "Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer". 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 pe...
What is the current status of trial NCT04915183?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2024-07-10. Estimated completion is 2030-08-31.
What conditions does trial NCT04915183 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Hearing Loss. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04915183?
The interventions under investigation include: Placebo (OTHER), Atorvastatin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04915183?
This trial is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD), which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04915183 being conducted?
This trial has 5 study locations across Georgia, Maryland, New York, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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