Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8NCT06662058
Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation
A study testing Audiometric Test and Interview in people with Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Head and Neck Carcinoma of Unknown Primary
- What is being tested?
- Audiometric Test and Interview
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory Midtown University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Nicole C. Schmitt, 404-778-1900, nicole.cherie.schmitt@emory.edu
Nicole C. Schmitt
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- To estimate the incidence and severity of cisplatin-induced hearing loss in head and neck squamous cell carcinoma (HNSCC).
TERTIARY/EXPLORATORY OBJECTIVE:
- 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.
- Conditions
- Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Head and Neck Carcinoma of Unknown Primary, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma
- Being tested
- Audiometric Test, Interview
- Medical subject headings
- Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Nasopharyngeal Carcinoma, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiometric TestProcedure or surgery
Also called Audiometric Testing, Audiometry, Hearing Test
Undergo audiometry
Audiometric TestProcedure or surgery
Also called Audiometric Testing, Audiometry, Hearing Test
Undergo close to home audiometry
Audiometric TestProcedure or surgery
Also called Audiometric Testing, Audiometry, Hearing Test
Undergo self-administered remote audiometry
InterviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (audiometry) | Active comparator | Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment. Receives: Procedure: Audiometric Test; Other: Interview |
| Group II, Arm I (audiometry) | Active comparator | Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I. Receives: Procedure: Audiometric Test; Other: Interview |
| Group II, Arm II (close to home audiometry, remote audiometry) | Experimental | 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. Receives: Procedure: Audiometric Test; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who complete at least one post-treatment audiogram
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.
Measured: Up to 12 months post-treatment
Secondary outcomes (1)
Incidence and severity of hearing loss
Assessed using Common Terminology Criteria for Adverse Events criteria and American Speech Language and Hearing Association criteria.
Measured: Up to 30 days following cessation of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start25 Aug 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Nicole Schmitt, Emory University
- Investigators
- Nicole C Schmitt, MD, FACS, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662058
- Sponsor's protocol ID
- STUDY00008286
- Other IDs
- K24DC022077, P30CA138292, NCI-2024-08456, STUDY00008286, WINSHIP6359-24
- Status last verified
- Jul 2026
- First submitted
- 25 Oct 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ototoxicity Monitoring and Remote Audiometry
- ClinicalTrials.gov ID
- NCT06662058
- Acronym / sponsor ID
- STUDY00008286
- Conditions
- Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Head and Neck Carcinoma of Unknown Primary, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- To estimate the incidence and severity of cisplatin-induced hearing loss in head and neck squamous cell carcinoma (HNSCC).
TERTIARY/EXPLORATORY OBJECTIVE:
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (audiometry) | Active comparator | Procedure: Audiometric Test, Other: InterviewPatients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment. |
| Group II, Arm I (audiometry) | Active comparator | Procedure: Audiometric Test, Other: InterviewPatients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I. |
| Group II, Arm II (close to home audiometry, remote audiometry) | Experimental | Procedure: Audiometric Test, Other: InterviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiometric TestAlso: Audiometric Testing, Audiometry, Hearing TestUndergo audiometry | Procedure or surgery | Group I (audiometry), Group II, Arm I (audiometry), Group II, Arm II (close to home audiometry, remote audiometry) |
| Audiometric TestAlso: Audiometric Testing, Audiometry, Hearing TestUndergo close to home audiometry | Procedure or surgery | Group II, Arm II (close to home audiometry, remote audiometry) |
| Audiometric TestAlso: Audiometric Testing, Audiometry, Hearing TestUndergo self-administered remote audiometry | Procedure or surgery | Group II, Arm II (close to home audiometry, remote audiometry) |
| InterviewAncillary studies | Other | Group I (audiometry), Group II, Arm I (audiometry), Group II, Arm II (close to home audiometry, remote audiometry) |
Primary outcome
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.
1 secondary outcome
Incidence and severity of hearing loss
Time frame: Up to 30 days following cessation of study participation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole C Schmitt, MD, FACS principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiometric Test and Interview in people with Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mo Oyewole (4047785351, mosope.desayo.oyewole@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who complete at least one post-treatment audiogram (time frame: Up to 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.