Remote hearing tests for patients with head and neck cancer receiving chemotherapy or radiation
Ototoxicity Monitoring and Remote Audiometry
This study is testing if remote hearing tests can help patients with advanced head and neck cancer keep track of their hearing loss during chemotherapy or radiation, making it easier for those who live far away to participate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06662058 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of remote audiometry in monitoring hearing loss in patients with advanced head and neck squamous cell carcinoma undergoing treatment with cisplatin and/or radiation. The study aims to increase participation in hearing loss monitoring by offering tests closer to home for patients living more than 120 miles away or those with stage IV disease. Patients are randomized into two groups: one receiving standard audiometry at a medical center and the other offered remote testing options. The trial also seeks to assess the incidence of cisplatin-induced hearing loss and identify barriers to participation in monitoring.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically proven head and neck squamous cell carcinoma receiving cisplatin and/or radiation.
Not a fit: Patients with profound hearing loss in both ears or those unable to participate in a hearing test will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance early detection of treatment-related hearing loss, improving quality of life for patients.
How similar studies have performed: Other studies have shown promise in remote monitoring approaches, but this specific intervention is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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/or parotid salivary gland * Life expectancy of more than 3 months, as determined by the investigator Exclusion Criteria: * Patients 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 * Patients who are unable to participate in a hearing test (per the investigator's judgment)
Where this trial is running
Atlanta, Georgia
- Emory Midtown University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Nicole C Schmitt, MD, FACS — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Mo Oyewole
- Email: mosope.desayo.oyewole@emory.edu
- Phone: 4047785351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.