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Chemotherapy
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
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.
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,704 Previous Clinical Trials
2,607,180 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,052 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
354 Previous Clinical Trials
181,617 Total Patients Enrolled
Nicole C Schmitt, MD, FACSPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute