Ototoxicity Monitoring and Remote Audiometry
Emory University
Summary
This clinical trial tests the impact of offering hearing tests (audiometry) close to home and remotely on participation in monitoring for treatment-related hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation. Cisplatin, a chemotherapy often used to treat head and neck cancers, and radiation given near the ear can cause hearing loss in some patients. Hearing loss can have a major negative impact on quality of life, contributing to social isolation and frustration. Identifying hearing changes may allow treatment changes to prevent further loss. Audiometry measures hearing loss using a graphic record of the softest sounds that a person can hear at various frequencies. It is recommended patients have a hearing test before, during and after treatment to monitor for any hearing loss. This is usually done in the office and performed on the same day as other visits whenever possible, however, patients who live far away or have stage IV cancer, may have more difficulty coming back for hearing tests. Offering close to home and remote audiometry may improve monitoring for hearing loss in patients with head and neck squamous cell cancer receiving cisplatin and/or radiation.
Description
PRIMARY OBJECTIVE: I. To determine whether a targeted intervention of remote audiometry offered to patients with advanced disease or living \> 120 miles away increases overall participation in ototoxicity monitoring. SECONDARY OBJECTIVE: I. To estimate the incidence and severity of cisplatin-induced hearing loss in head and neck squamous cell carcinoma (HNSCC). TERTIARY/EXPLORATORY OBJECTIVE: I. To identify potential barriers to ototoxicity monitoring participation, from the patient perspective. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients undergo audiometry at W…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult patients, male or female, aged ≥ 18, able to provide informed consent * Subjects with pathologically proven HNSCC involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, skin, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can also be included. Patients can have previously untreated or recurrent/metastatic disease * Subjects who will be treated with cisplatin chemotherapy and/or radiation. For radiation alone, patients should have tumors near the inner ear, including the nasopharynx, temporal bone, and/…
Interventions
- ProcedureAudiometric Test
Undergo audiometry
- ProcedureAudiometric Test
Undergo close to home audiometry
- ProcedureAudiometric Test
Undergo self-administered remote audiometry
- OtherInterview
Ancillary studies
Location
- Emory Midtown University Hospital/Winship Cancer InstituteAtlanta, Georgia