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Ototoxicity Screening for Head and Neck Cancer Survivors
N/A
Recruiting
Led By David Lee, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 6 months)
Awards & highlights
Study Summary
This trial will measure the usefulness and safety of an ototoxicity screening protocol for H&N cancer patients who had CRT.
Who is the study for?
This trial is for adults over 18 who have had cisplatin-based chemoradiation therapy to treat head and neck cancer. It's not for those who use hearing aids, have cochlear implants, can't fill out forms in English, or saw an audiologist in the last year.Check my eligibility
What is being tested?
The study is testing a special screening process to check for hearing damage (ototoxicity) in people who've been treated for head and neck cancers with a specific chemotherapy drug.See study design
What are the potential side effects?
Since this trial involves only screening procedures rather than medication or invasive treatments, there are no direct side effects associated with the interventions being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 6 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of participants who complete audiologic follow-up
Secondary outcome measures
Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure
Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure
Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Ototoxicity Screening ProtocolExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,696 Total Patients Enrolled
American Academy of Otolaryngology-Head and Neck Surgery FoundationOTHER
9 Previous Clinical Trials
1,336 Total Patients Enrolled
David Lee, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
1,099 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had cisplatin-based treatment or radiotherapy for head and neck cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Ototoxicity Screening Protocol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrolment open to potential participants in this experiment?
"This clinical trial, which was added to the registry on April 30th 2023 and last modified on March 16th 2023, is no longer actively recruiting participants. Nonetheless, 419 other medical studies are still enrolling patients at this time."
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