[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566967":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":47,"centralContacts":52,"locations":58,"responsibleParty":79,"collaborators":82,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":46,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":46,"enrollmentInfo":97,"targetDuration":46,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":46,"overallStatus":61,"whyStopped":46,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Emory University","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group I (audiometry)","ACTIVE_COMPARATOR","Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and\u002For radiation treatment.",[13,14],"Procedure: Audiometric Test","Other: Interview",{"label":16,"type":10,"description":17,"interventionNames":18},"Group II, Arm I (audiometry)","Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and\u002For radiation treatment as in Group I.",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"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\u002For radiation treatment.",[13,14],[25,34,38,42],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Audiometric Test","Undergo audiometry",[9,16,20],[31,32,33],"Audiometric Testing","Audiometry","Hearing Test",{"type":26,"name":27,"description":35,"armGroupLabels":36,"otherNames":37},"Undergo close to home audiometry",[20],[31,32,33],{"type":26,"name":27,"description":39,"armGroupLabels":40,"otherNames":41},"Undergo self-administered remote audiometry",[20],[31,32,33],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Interview","Ancillary studies",[9,16,20],null,[48],{"name":49,"affiliation":50,"role":51},"Nicole C Schmitt, MD, FACS","Emory University Hospital\u002FWinship Cancer Institute","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":46,"email":57},"Mo Oyewole","CONTACT","4047785351","mosope.desayo.oyewole@emory.edu",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Emory Midtown University Hospital\u002FWinship Cancer Institute","RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-84.38798,33.749,{"lat":71,"lon":70},[74,78],{"name":75,"role":55,"phone":76,"phoneExt":46,"email":77},"Nicole C. Schmitt","404-778-1900","nicole.cherie.schmitt@emory.edu",{"name":75,"role":51,"phone":46,"phoneExt":46,"email":46},{"type":51,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Nicole Schmitt","Principal Investigator",[83,86],{"name":84,"class":85},"National Cancer Institute (NCI)","NIH",{"name":87,"class":85},"National Institute on Deafness and Other Communication Disorders (NIDCD)","100566967","remote-audiometry-to-monitor-for-treatment-related-hearing-loss-in-patients-with-hn-scc-receiving-cisplatin-andor-radiation-100566967",false,"NCT06662058","Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and\u002For Radiation","Ototoxicity Monitoring and Remote Audiometry","Inclusion Criteria:\n\n* Adult patients, male or female, aged ≥ 18, able to provide informed consent\n* 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\u002Fmetastatic disease\n* Subjects who will be treated with cisplatin chemotherapy and\u002For radiation. For radiation alone, patients should have tumors near the inner ear, including the nasopharynx, temporal bone, and\u002For parotid salivary gland\n* Life expectancy of more than 3 months, as determined by the investigator\n\nExclusion Criteria:\n\n* Patients with profound hearing loss in both ears, which precludes an accurate hearing test. This can be determined based on patient report\u002Fhistory or audiogram done before or after informed consent\n* Patients who are unable to participate in a hearing test (per the investigator's judgment)","ALL","18 Years",{"count":98,"type":99},118,"ESTIMATED","INTERVENTIONAL",[102],"NA","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\u002For 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\u002For radiation.",[105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137],"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","2026-04-20",{"date":140,"type":141},"2026-04-23","ACTUAL",{"date":143,"type":141},"2025-03-12",{"date":145,"type":99},"2029-10-31",{"name":5,"class":6},1]