Remote Audiometry for Hearing Loss in Head and Neck Cancers

Recruiting in Palo Alto (17 mi)

Nicole C. Schmitt, MD, FACS | Winship ...

Overseen byNicole C. Schmitt, MD, FACS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Emory University

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of 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 is for patients with various types of head and neck squamous cell cancers who are undergoing treatment with cisplatin and/or radiation. It aims to make hearing tests more accessible by offering them close to home or remotely, especially benefiting those living far from the hospital or with advanced-stage cancer.

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

Participant Groups

The study is evaluating whether providing audiometry (hearing tests) near a patient's home or through remote methods can improve monitoring for hearing loss caused by cisplatin chemotherapy and/or radiation therapy in head and neck cancer patients.

3Treatment groups

Experimental Treatment

Active Control

Group I: Group II, Arm II (close to home audiometry, remote audiometry)Experimental Treatment2 Interventions

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.

Group II: Group I (audiometry)Active Control2 Interventions

Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment.

Group III: Group II, Arm I (audiometry)Active Control2 Interventions

Patients undergo audiometry at WEM at baseline and at 3 and 12 months after chemotherapy and/or radiation treatment as in Group I.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: