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NCT06662058 | RECRUITING | Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

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

Emory University

Information provided by (Responsible Party):

Nicole Schmitt

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.

Condition or disease

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 hypophorngeal Carcinoma Ajc V8

Stage IV Laryngeal Cancer Ajc V8

Stage IV Lip and Oral Cavity Cancer AJCC v8

Stage IV Nasopharynnal CARCINOMA AJCC V8

Stage IV oropharyngeal (P16-Negative) Carcinoma Ajc V8

Stage IV Sinonasal Cancer Ajcc V8

Intervention/treatment

Audiometric Test

Audiometric Test

Audiometric Test

Interview

Phase

NA

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
Estimated Enrollment : 118 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Ototoxicity Monitoring and Remote Audiometry
Actual Study Start Date : 2025-03-12
Estimated Primary Completion Date : 2028-10-31
Estimated Study Completion Date : 2029-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation

Location Details

NCT06662058

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How to Participate

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Locations

RECRUITING

United States, Georgia

Emory Midtown University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322