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

ConditionsClinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Cutaneous Squamous Cell Carcinoma of the Head and NeckHead and Neck Carcinoma of Unknown PrimaryHead and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaMetastatic Cutaneous Squamous Cell Carcinoma of the Head and NeckMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Nasopharyngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaMetastatic Paranasal Sinus Squamous Cell CarcinomaNasopharyngeal Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaOropharyngeal Squamous Cell CarcinomaParanasal Sinus Squamous Cell CarcinomaRecurrent Cutaneous Squamous Cell Carcinoma of the Head and NeckRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Nasopharyngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Paranasal Sinus Squamous Cell CarcinomaStage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Nasopharyngeal Carcinoma AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Sinonasal Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Audiometric Test

    Procedure/Surgery

    Undergo audiometry

  • Audiometric Test

    Procedure/Surgery

    Undergo close to home audiometry

  • Audiometric Test

    Procedure/Surgery

    Undergo self-administered remote audiometry

  • Interview

    Other intervention

    Ancillary studies

Treatment groups

118 Participants
are divided into 3 treatment groups
Group A: Group I (audiometry)Active comparator 2 interventions
Group B: Group II, Arm I (audiometry)Active comparator 2 interventions
Group C: Group II, Arm II (close to home audiometry, remote audiometry)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients who complete at least one post-treatment audiogram

The incidence of follow-up audiometry relative to the targeted intervention will be assessed using a Z test for the equality of two proportions. An ordinal logistic regression analysis with mixed effects and calculations of odds ratios and 95% confidence intervals will be applied to identify associations between follow-up audiometry and intervention after adjustment for covariates including age, sex, race/ethnicity, pre-existing hearing loss, comorbidities, smoking, cisplatin dose (individual and cumulative) and cochlear radiation dose will be performed to assess whether the targeted intervention for at-risk patients is an independent predictor of increased overall participation.

Time frame
Up to 12 months post-treatment

Secondary outcomes

1

Incidence and severity of hearing loss

Assessed using Common Terminology Criteria for Adverse Events criteria and American Speech Language and Hearing Association criteria.

Time frame
Up to 30 days following cessation of study participation

Other outcomes

1

To identify potential barriers to ototoxicity monitoring participation

Qualitative data from patient interviews focused on barriers to ototoxicity monitoring.

Time frame
Up to 18 months post-treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov
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