Actively Recruiting
Ototoxicity Monitoring and Remote Audiometry to Improve Hearing Loss Monitoring in Patients with Head and Neck Squamous Cell Carcinoma Receiving Cisplatin and/or Radiation
Led by Emory University · Updated on 2026-04-23
118
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether offering hearing tests closer to home or remotely can improve participation in monitoring hearing loss caused by treatment in patients with head and neck squamous cell cancer receiving cisplatin chemotherapy and/or radiation. Hearing loss from these treatments can seriously affect quality of life by causing social isolation and frustration. The study aims to better understand hearing loss incidence and find barriers to monitoring from the patient perspective. Participants are randomly assigned to one of two groups. One group receives traditional hearing tests at the main clinic at the start, 3 months, and 12 months after treatment. The other group has hearing tests at the clinic at the start but can choose close to home or self-administered remote hearing tests at 3 and 12 months post-treatment. This approach is targeted especially for patients with stage IV disease or those living over 120 miles away, who may find travel difficult. During the study, participants will undergo audiometry to measure hearing ability before treatment and at set times afterward. Researchers will track how many patients complete hearing tests after treatment, measure any hearing loss severity, and conduct interviews to identify participation barriers. The monitoring period extends up to 12 months post-treatment, with additional follow-up to assess hearing loss up to 30 days after study participation ends.
CONDITIONS
Brief Title
Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older, male or female, able to provide informed consent
- Diagnosed with head and neck squamous cell carcinoma involving oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, skin, or paranasal sinuses, including unknown primary involving cervical lymph nodes
- Patients may have untreated, recurrent, or metastatic disease
- Scheduled to receive cisplatin chemotherapy and/or radiation near the inner ear (nasopharynx, temporal bone, or parotid gland)
- Life expectancy of more than 3 months as determined by investigator
You will not qualify if you...
- Profound hearing loss in both ears that prevents accurate hearing testing
- Unable to participate in hearing tests as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and up to 12 months after treatment
Participants undergo audiometry to monitor hearing before and after chemotherapy and/or radiation treatment.
1 baseline visit and 2 follow-up visits at 3 and 12 months post-treatment
Trial Site Locations
Total: 1 location
1
Emory Midtown University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
M
Mo Oyewole
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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