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Recruiting NCT06662058

NCT06662058 Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation

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Clinical Trial Summary
NCT ID NCT06662058
Status Recruiting
Phase
Sponsor Emory University
Condition Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Study Type INTERVENTIONAL
Enrollment 118 participants
Start Date 2025-03-12
Primary Completion 2028-10-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
All 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 Metastatic Cutaneous Squamous Cell Carcinoma of the Head and Neck Metastatic Head and Neck Squamous Cell Carcinoma Metastatic Hypopharyngeal Squamous Cell Carcinoma Metastatic Laryngeal Squamous Cell Carcinoma Metastatic Nasopharyngeal Squamous Cell Carcinoma Metastatic Oral Cavity Squamous Cell Carcinoma Metastatic Oropharyngeal Squamous Cell Carcinoma Metastatic Paranasal Sinus Squamous Cell Carcinoma Nasopharyngeal Squamous Cell Carcinoma Oral Cavity Squamous Cell Carcinoma Oropharyngeal Squamous Cell Carcinoma Paranasal Sinus Squamous Cell Carcinoma Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck Recurrent Head and Neck Squamous Cell Carcinoma Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Nasopharyngeal Squamous Cell Carcinoma Recurrent Oral Cavity Squamous Cell Carcinoma Recurrent Oropharyngeal Squamous Cell Carcinoma Recurrent Paranasal Sinus Squamous Cell Carcinoma Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage IV Hypopharyngeal Carcinoma AJCC v8 Stage IV Laryngeal Cancer AJCC v8 Stage IV Lip and Oral Cavity Cancer AJCC v8 Stage IV Nasopharyngeal Carcinoma AJCC v8 Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage IV Sinonasal Cancer AJCC v8
Interventions
Audiometric TestAudiometric TestAudiometric Test

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 118 participants in total. It began in 2025-03-12 with a primary completion date of 2028-10-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility 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)

Contact & Investigator

Central Contact

Mo Oyewole

✉ mosope.desayo.oyewole@emory.edu

📞 4047785351

Principal Investigator

Nicole C Schmitt, MD, FACS

PRINCIPAL INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Frequently Asked Questions

Who can join the NCT06662058 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06662058 currently recruiting?

Yes, NCT06662058 is actively recruiting participants. Contact the research team at mosope.desayo.oyewole@emory.edu for enrollment information.

Where is the NCT06662058 trial being conducted?

This trial is being conducted at Atlanta, United States.

Who is sponsoring the NCT06662058 clinical trial?

NCT06662058 is sponsored by Emory University. The principal investigator is Nicole C Schmitt, MD, FACS at Emory University Hospital/Winship Cancer Institute. The trial plans to enroll 118 participants.

ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology