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NCT02099786 · ClinicalTrials.gov registry record · NA
Randomized Trial Comparison of Ototoxicity Monitoring Programs
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 47
- Enrollment target
NCT02099786: Completed NA study, sponsored by VA Office of Research and Development.
NCT02099786 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02099786, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 47 participants
- Enrollment target
Study Summary
This study involves research. Some chemotherapeutic drugs that can permanently reduce hearing are termed "ototoxic". One such drug is the chemotherapy called cisplatin. Currently, if a patient is receiving cisplatin, hearing is tested in the Audiology Clinic using lengthy protocols and may be retested only when it is requested by their oncologist and when the Veteran can arrange an appointment. Researchers think that hearing testing prior to every treatment of cisplatin may reduce the number of Veterans who get disabling hearing loss from treatment. The purpose of this study is to compare the current method of monitoring hearing (audiology clinic protocols termed "usual care") with a new portable hearing monitoring program (a comprehensive program of ototoxicity monitoring termed "COMP-VA") that tests hearing using a portable hearing testing audiometer and a variety of efficient tools and techniques so that testing can occur prior to each cisplatin treatment at any quiet location in the hospital.
Primary Outcome
Veterans randomized to the COMP-VA arm will have improved hearing outcomes (a) fewer ASHA-significant threshold shifts, (b) fewer CTCAE grade 1 or greater hearing shifts at Program Evaluation 3 as compared with Veterans randomized to the Usual Care arm. 1. ASHA Shift is defined as: 20 dB shift at a single frequency 10 dB shift at two adjacent frequencies loss of response at three adjacent frequencies 2. CTCAE Grade 1 or greater ototoxicity = hearing shift of 15-25 dB averaged at 2 contiguou
Interventions
- OTHER Standard of care
- OTHER COMP-VA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2015-04-01 |
| Est. Completion | 2018-05-05 |
| Phase | NA |
What the finished NCT02099786 record still lists
NCT02099786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT02099786 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02099786 about?
NCT02099786 is a clinical study titled "Randomized Trial Comparison of Ototoxicity Monitoring Programs". This study involves research. Some chemotherapeutic drugs that can permanently reduce hearing are termed "ototoxic". One such drug is the chemotherapy called cisplatin. Currently, if a patient is receiving cisplatin, hearing is tested in the Audiology Clinic using lengthy protocols and may be retest...
What is the current status of trial NCT02099786?
This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2015-04-01. Estimated completion is 2018-05-05.
What interventions are being tested in trial NCT02099786?
The interventions under investigation include: Standard of care (OTHER), COMP-VA (OTHER).
Who is sponsoring clinical trial NCT02099786?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02099786's enrollment target sits among peer trials
47 1400th of 2000 higher than 599 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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