This trial tests the effectiveness of a hearing screening testing protocol to detect hearing loss or damage (ototoxicity) in head and neck cancer survivors after cisplatin-based chemoradiation therapy (CRT). More than 40% of head and neck (H&N) cancer patients treated with cisplatin-based CRT develop hearing loss that is progressive and irreversible. This can result in impaired communication and can decrease quality of life (QoL). There is an effective therapy for treatment-related hearing loss (auditory rehabilitation), but only 10% of patients seek evaluation after 6 months. The ototoxicity screening protocol may identify those who may benefit most from auditory rehabilitation and may improve hearing loss monitoring in head and neck cancer survivors who have been treated with cisplatin-based chemoradiation therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT05789316.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: David S. Lee
Phone: 314-393-4736
PRIMARY OBJECTIVE:
I. To determine the feasibility and effectiveness of a tablet-based ototoxicity screening protocol for H&N cancer patients treated with cisplatin-based CRT followed in survivorship clinic.
SECONDARY OBJECTIVE:
I. To determine the impact of late and long-term treatment-related ototoxicity on QoL in H&N cancer survivorship.
II. To determine the prevalence of late and long-term ototoxicity associated with H&N cancer patients in survivorship clinic.
OUTLINE: Patients complete the tablet-based ototoxicity screening protocol via a survey about their current hearing level and pure tone audiometry before their survivorship clinic visit. Patients then recieve counseling on ototoxicity and referral to audiology regardless of screening status during their survivorship clinic visit. Patients also undergo another pure tone audiometry and complete additional surveys on hearing after their survivorship clinic visit.
After completion of the study intervention, patients are followed up at 6 months via chart review or phone.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorDavid S. Lee