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Official Title

Ototoxicity Monitoring and Remote Audiometry

Sponsor
Emory University
Enrollment
118
Timeline
Mar 2025 → Oct 2029
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Adult patients, male or female, aged ≥ 18, able to provide informed consent
  • 2Subjects 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
  • 3Subjects 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/or parotid salivary gland
  • 4Life expectancy of more than 3 months, as determined by the investigator

Exclusion Criteria

  • 1Patients with profound hearing loss in both ears, which precludes an accurate hearing test. This can be determined based on patient report/history or audiogram done before or after informed consent
  • 2Patients who are unable to participate in a hearing test (per the investigator's judgment)

Locations

1 site participating in this study

Emory Midtown University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Nicole C. Schmitt

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →