Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation

April 20, 2026 updated by: Nicole Schmitt, Emory University

Ototoxicity Monitoring and Remote Audiometry

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Midtown University Hospital/Winship Cancer Institute
        • Contact:
        • Principal Investigator:
          • Nicole C. Schmitt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I (audiometry)
Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.
Other: Interview
Ancillary studies
Procedure: Audiometric Test
Undergo audiometry
Other Names:
  • Audiometry
  • Audiometric Testing
  • Hearing Test
Procedure: Audiometric Test
Undergo close to home audiometry
Other Names:
  • Audiometry
  • Audiometric Testing
  • Hearing Test
Procedure: Audiometric Test
Undergo self-administered remote audiometry
Other Names:
  • Audiometry
  • Audiometric Testing
  • Hearing Test
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.
Other: Interview
Ancillary studies
Procedure: Audiometric Test
Undergo audiometry
Other Names:
  • Audiometry
  • Audiometric Testing
  • Hearing Test
Procedure: Audiometric Test
Undergo close to home audiometry
Other Names:
  • Audiometry
  • Audiometric Testing
  • Hearing Test
Procedure: Audiometric Test
Undergo self-administered remote audiometry
Other Names:
  • Audiometry
  • Audiometric Testing
  • Hearing Test
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.
Other: Interview
Ancillary studies
Procedure: Audiometric Test
Undergo audiometry
Other Names:
  • Audiometry
  • Audiometric Testing
  • Hearing Test
Procedure: Audiometric Test
Undergo close to home audiometry
Other Names:
  • Audiometry
  • Audiometric Testing
  • Hearing Test
Procedure: Audiometric Test
Undergo self-administered remote audiometry
Other Names:
  • Audiometry
  • Audiometric Testing
  • Hearing Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who complete at least one post-treatment audiogram
Time Frame: Up to 12 months post-treatment
The incidence of follow-up audiometry relative to the targeted intervention will be assessed using a Z test for the equality of two proportions. An ordinal logistic regression analysis with mixed effects and calculations of odds ratios and 95% confidence intervals will be applied to identify associations between follow-up audiometry and intervention after adjustment for covariates including age, sex, race/ethnicity, pre-existing hearing loss, comorbidities, smoking, cisplatin dose (individual and cumulative) and cochlear radiation dose will be performed to assess whether the targeted intervention for at-risk patients is an independent predictor of increased overall participation.
Up to 12 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of hearing loss
Time Frame: Up to 30 days following cessation of study participation
Assessed using Common Terminology Criteria for Adverse Events criteria and American Speech Language and Hearing Association criteria.
Up to 30 days following cessation of study participation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify potential barriers to ototoxicity monitoring participation
Time Frame: Up to 18 months post-treatment
Qualitative data from patient interviews focused on barriers to ototoxicity monitoring.
Up to 18 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Nicole C Schmitt, MD, FACS, Emory University Hospital/Winship Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2029

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008286 (Other Identifier: Emory University Hospital/Winship Cancer Institute)
  • P30CA138292 (U.S. NIH Grant/Contract)
  • K24DC022077 (U.S. NIH Grant/Contract)
  • NCI-2024-08456 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • WINSHIP6359-24 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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