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NCT03225157 · ClinicalTrials.gov registry record
Hearing Loss and the Effects of Statin Drugs in People With Head and Neck Squamous Cell Carcinoma Treated With Cisplatin Chemoradiation
A clinical trial, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- Completed
- Registry status
- 32
- Enrollment target
NCT03225157: Completed study, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
NCT03225157 is a clinical trial that has completed, run by National Institute on Deafness and Other Communication Disorders (NIDCD). The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03225157 has completed, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
Study Summary
Background: Cisplatin is a chemotherapy drug. It is used to treat head and neck squamous cell carcinoma (HNSCC) and other cancers. It can cause hearing loss for some people. It is not known how many people will get hearing loss from cisplatin. It is also not known what other factors might influence who gets hearing loss. Factors could include age, sex, noise exposure, and other drugs the person is taking. Statins are drugs used to lower cholesterol. Statins may also reduce cisplatin-induced hearing loss. Objectives: To see if statins reduce hearing loss in people getting cisplatin therapy to treat HNSCC. To find out how many people taking cisplatin get hearing loss from it. To find out if other factors might influence whether cisplatin causes hearing loss. Eligibility: People ages 18 and older who are getting treatment with cisplatin for HNSCC Design: Participants will be screened with a review of their medical records. Participants will have 3 visits. These will be before the onset of cisplatin therapy, at about 4 weeks after they finish therapy, and about 6 months after they finish therapy. Each visit will include: Medication history Audiogram/hearing tests. Participants will wear headphones and indicate when they hear different sounds. Questions about their noise exposure history and whether they have ringing in the ears
Primary Outcome
The primary outcome measure is the change in hearing sensitivity (as measured by the self-administered audiogram) 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 TUNE and ASHA criteria and will be compared in subjects taking statin drugs vs. subjects not taking statin drugs. Hearing status will be compared between audiograms collected at baseline (prior to treatme
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-11-03 |
| Est. Completion | 2020-02-28 |
What the finished NCT03225157 record still lists
NCT03225157 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03225157 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03225157 about?
NCT03225157 is a clinical study titled "Hearing Loss and the Effects of Statin Drugs in People With Head and Neck Squamous Cell Carcinoma Treated With Cisplatin Chemoradiation". Background: Cisplatin is a chemotherapy drug. It is used to treat head and neck squamous cell carcinoma (HNSCC) and other cancers. It can cause hearing loss for some people. It is not known how many people will get hearing loss from cisplatin. It is also not known what other factors might influence...
What is the current status of trial NCT03225157?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2017-11-03. Estimated completion is 2020-02-28.
Who is sponsoring clinical trial NCT03225157?
This trial is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD), which has 34 total clinical trials registered on ClinicalTrials.gov.
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