Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)
NCT ID: NCT05789316
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2023-06-06
2025-11-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Ototoxicity Screening Protocol
After enrollment, participants will complete a pre-screening survey. Before their survivorship clinic visit, participants will complete the ototoxicity screening protocol and implementation outcome surveys. During their visit, they will receive counseling on ototoxicity and referral to audiology. After their visit, they will complete the SESMQ and WU-QOLv4 surveys and undergo pure tone audiometry. Each participant will complete this protocol once. The investigators will follow each participant by chart review for at least six months to evaluate for audiologic follow-up.
Ototoxicity Screening Protocol
The ototoxicity screening protocol contains a functional and objective component. The functional component is the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S). The objective component will be pure tone audiometry. A 2 kHz tone at 40 dB will play through over-the-ear headphones and subjects will indicate whether they heard it.
Interventions
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Ototoxicity Screening Protocol
The ototoxicity screening protocol contains a functional and objective component. The functional component is the Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S). The objective component will be pure tone audiometry. A 2 kHz tone at 40 dB will play through over-the-ear headphones and subjects will indicate whether they heard it.
Eligibility Criteria
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Inclusion Criteria
* H\&N cancer patients will be eligible for inclusion if they have previously undergone cisplatin-based CRT or radiotherapy, including proton therapy, intensity-modulated radiation therapy, and adaptive radiotherapy-surgery with curative intent (i.e., definitive, neoadjuvant, or adjuvant) or definitive surgery with neoadjuvant or adjuvant radiation.
Exclusion Criteria
* Use of a hearing aid
* Received a cochlear implant
* Cannot complete simple forms in English
18 Years
ALL
No
Sponsors
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American Academy of Otolaryngology-Head and Neck Surgery Foundation
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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David Lee, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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202302038
Identifier Type: -
Identifier Source: org_study_id
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