Recruiting

Cisplatin & Radiation

Sponsor:

Emory University

Code:

NCT06662058

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Audiometric Test

Audiometric Test

Audiometric Test

Interview

Study Details

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.

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

Study ID

NCT06662058

Start date

Aug 25, 2025

Status verified date

Jul, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

Audiometric Test

Undergo audiometry

Audiometric Test

Undergo close to home audiometry

Audiometric Test

Undergo self-administered remote audiometry

Interview

Ancillary studies

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mo Oyewole

4047785351mosope.desayo.oyewole@emory.edu

Locations

Emory Midtown University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Nicole C. Schmitt

404-778-1900nicole.cherie.schmitt@emory.edu

Principal Investigator:

Nicole C. Schmitt

More Information

Sponsor

Emory University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-07-16.