Remote Audiometry to Monitor for Treatment-Related Hearing Loss in Patients With H&N SCC Receiving Cisplatin and/or Radiation
Ototoxicity Monitoring and Remote Audiometry
5 other identifiers
interventional
118
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2024
CompletedFirst Posted
Study publicly available on registry
October 28, 2024
CompletedStudy Start
First participant enrolled
March 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2029
April 23, 2026
April 1, 2026
3.6 years
October 25, 2024
April 20, 2026
Conditions
Outcome Measures
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.
Up to 12 months post-treatment
Secondary Outcomes (1)
Incidence and severity of hearing loss
Up to 30 days following cessation of study participation
Other Outcomes (1)
To identify potential barriers to ototoxicity monitoring participation
Up to 18 months post-treatment
Study Arms (3)
Group I (audiometry)
ACTIVE COMPARATORPatients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.
Group II, Arm I (audiometry)
ACTIVE COMPARATORPatients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I.
Group II, Arm II (close to home audiometry, remote audiometry)
EXPERIMENTALPatients 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
Undergo audiometry
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emory Midtown University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole C Schmitt, MD, FACS
Emory University Hospital/Winship Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 25, 2024
First Posted
October 28, 2024
Study Start
March 12, 2025
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
October 31, 2029
Last Updated
April 23, 2026
Record last verified: 2026-04