Ototoxicity Monitoring and Remote Audiometry

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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/or parotid salivary gland

• Life expectancy of more than 3 months, as determined by the investigator

Locations
United States
Georgia
Emory Midtown University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Contact Information
Primary
Mo Oyewole
mosope.desayo.oyewole@emory.edu
4047785351
Time Frame
Start Date: 2025-03-12
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 118
Treatments
Active_comparator: Group I (audiometry)
Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.
Active_comparator: Group II, Arm I (audiometry)
Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I.
Experimental: Group II, Arm II (close to home audiometry, remote audiometry)
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.
Sponsors
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), National Cancer Institute (NCI)
Leads: Emory University

This content was sourced from clinicaltrials.gov