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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 after survivorship clinic visit (day 1)

Awards & highlights

No Placebo-Only Group

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.

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.

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 ~ after survivorship clinic visit (day 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after survivorship clinic visit (day 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after survivorship clinic visit (day 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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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