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RecruitingNot ApplicableNCT06662058

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

Ototoxicity Monitoring and Remote Audiometry

Sponsor

Emory University

Enrollment

118 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell CarcinomaMetastatic Head and Neck Squamous Cell CarcinomaStage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Recurrent Head and Neck Squamous Cell CarcinomaClinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Metastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaStage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Oropharyngeal Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaMetastatic Nasopharyngeal Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Nasopharyngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaStage IV Nasopharyngeal Carcinoma AJCC v8Stage IV Sinonasal Cancer AJCC v8Cutaneous Squamous Cell Carcinoma of the Head and NeckHead and Neck Carcinoma of Unknown PrimaryHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaMetastatic Cutaneous Squamous Cell Carcinoma of the Head and NeckMetastatic Paranasal Sinus Squamous Cell CarcinomaNasopharyngeal Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaParanasal Sinus Squamous Cell CarcinomaRecurrent Cutaneous Squamous Cell Carcinoma of the Head and NeckRecurrent Paranasal Sinus Squamous Cell Carcinoma

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria2

  • 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)

Interventions

PROCEDUREAudiometric Test

Undergo audiometry

PROCEDUREAudiometric Test

Undergo close to home audiometry

PROCEDUREAudiometric Test

Undergo self-administered remote audiometry

OTHERInterview

Ancillary studies

Locations(1)

Emory Midtown University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

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NCT06662058

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