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NCT04915183 · ClinicalTrials.gov registry record · Phase 2
Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
A Phase 2 study of Head and Neck Cancer and Hearing Loss, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 224
- Enrollment target
- 5
- Study locations
NCT04915183 is a Phase 2 study of Head and Neck Cancer and Hearing Loss that is actively recruiting participants, run by National Institute on Deafness and Other Communication Disorders (NIDCD). The registered enrollment target is 224 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (14% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT04915183, a Phase 2 study of Head and Neck Cancer and Hearing Loss, is actively recruiting participants, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 224 participants
- Enrollment target
- 5
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (14% lower). The listed sponsor is National Institute on Deafness and Other Communication Disorders (NIDCD), which has 34 total studies on file at ClinicalTrials.gov.
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.
NCT04915183 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Maryland, Georgia, New York.
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.
What interventions are being tested in trial NCT04915183?
The interventions under investigation include: Placebo (OTHER), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT04915183?
This trial is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD), which has 34 total clinical trials registered on ClinicalTrials.gov.
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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