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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: Recruiting Phase 2 study of Head and Neck Cancer and Hearing Loss, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint is the change in hearing sensitivity (as measured by pure-tone audiometry) between the pre-treatment (before cisplatin therapy) hearing test and the post-treatment (after completion of cisplatin therapy) audiogram. Hearing loss will be defined according to CTCAE criteria and will be compared in subjects taking atorvastatin vs. subjects not taking any statin drug. Hearing sensitivity will be compared between audiograms collected at baseline (prior to treatment) to a repeated
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 |
What NCT04915183 shows while recruiting
NCT04915183 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (14% lower).
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 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
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Where NCT04915183's enrollment target sits among peer trials
224 47th of 250 higher than 204 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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