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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group I (audiometry) 		Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.
  • Procedure: Audiometric Test
    Undergo audiometry
    Other names:
    • Audiometric Testing
    • Audiometry
    • Hearing Test
  • Other: Interview
    Ancillary studies
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.
  • Procedure: Audiometric Test
    Undergo audiometry
    Other names:
    • Audiometric Testing
    • Audiometry
    • Hearing Test
  • Other: Interview
    Ancillary studies
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.
  • Procedure: Audiometric Test
    Undergo audiometry
    Other names:
    • Audiometric Testing
    • Audiometry
    • Hearing Test
  • Procedure: Audiometric Test
    Undergo close to home audiometry
    Other names:
    • Audiometric Testing
    • Audiometry
    • Hearing Test
  • Procedure: Audiometric Test
    Undergo self-administered remote audiometry
    Other names:
    • Audiometric Testing
    • Audiometry
    • Hearing Test
  • Other: Interview
    Ancillary studies

Recruiting Locations

Emory Midtown University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Contact:
Nicole C. Schmitt
404-778-1900
nicole.cherie.schmitt@emory.edu

More Details

Status
Recruiting
Sponsor
Emory University

Study Contact

Mo Oyewole
4047785351
mosope.desayo.oyewole@emory.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.