Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT06662058
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2024-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Ototoxicity Monitoring and Remote Audiometry
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Winship Emory Midtown (WEM) at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.
GROUP II: Patients who do not live \> 120 miles away or do not have stage IV disease are assigned to Arm I. Patients who do live \> 120 miles away or who have stage IV disease are assigned to Arm II.
ARM I (USUAL): Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I.
ARM II (INTERVENTION): 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.
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 Winship Emory Midtown (WEM) at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.
GROUP II: Patients who do not live \> 120 miles away or do not have stage IV disease are assigned to Arm I. Patients who do live \> 120 miles away or who have stage IV disease are assigned to Arm II.
ARM I (USUAL): Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I.
ARM II (INTERVENTION): 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K24DC022077 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA138292 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2024-08456 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STUDY00008286 | OTHER | Emory University Hospital/Winship Cancer Institute | View | |
| WINSHIP6359-24 | OTHER | Emory University Hospital/Winship Cancer Institute | View |