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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06662058
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Audiometric Test — PROCEDURE
    Undergo audiometry
  • Audiometric Test — PROCEDURE
    Undergo close to home audiometry
  • Audiometric Test — PROCEDURE
    Undergo self-administered remote audiometry
  • Interview — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Mar 12, 2025
Status verified
Apr 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Group I (audiometry)
    Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.
  • Active Comparator: Group II, Arm I (audiometry)
    Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I.
  • Experimental: Group II, Arm II (close to home audiometry, remote audiometry)
    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.

Primary Outcome Measure

Proportion of patients who complete at least one post-treatment audiogram [ Time Frame: Up to 12 months post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory Midtown University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Nicole C. Schmitt
[email protected]
404-778-1900
Nicole C. Schmitt (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Emory Midtown University Hospital/Winship Cancer Institute· Atlanta, GA

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