Remote Audiometry for Hearing Loss in Head and Neck Cancers

N/A

Waitlist Available

Led By Nicole C Schmitt, MD, FACS

Research Sponsored by Emory University

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 up to 18 months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing if offering hearing tests at home or remotely can help monitor and prevent treatment-related hearing loss in patients with head and neck cancer receiving chemotherapy and radiation. These treatments can cause hearing loss,

Who is the study for?

This trial is for patients with various types of head and neck squamous cell cancers who are undergoing treatment with cisplatin and/or radiation. It aims to make hearing tests more accessible by offering them close to home or remotely, especially benefiting those living far from the hospital or with advanced-stage cancer.

What is being tested?

The study is evaluating whether providing audiometry (hearing tests) near a patient's home or through remote methods can improve monitoring for hearing loss caused by cisplatin chemotherapy and/or radiation therapy in head and neck cancer patients.

What are the potential side effects?

While this trial focuses on monitoring side effects rather than causing them, it's important to note that the treatments being monitored—cisplatin chemotherapy and radiation—can lead to hearing loss, which this study seeks to detect early.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months post-treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of patients who complete at least one post-treatment audiogram

Secondary study objectives

Incidence and severity of hearing loss

Other study objectives

To identify potential barriers to ototoxicity monitoring participation

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group II, Arm II (close to home audiometry, remote audiometry)Experimental Treatment2 Interventions

Patients undergo audiometry at WEM at baseline and are offered closer to home audiometry or self-administered remote audiometry at 3 and 12 months after chemotherapy and/or radiation treatment.

Group II: Group I (audiometry)Active Control2 Interventions

Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.

Group III: Group II, Arm I (audiometry)Active Control2 Interventions

Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I.

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