Remote Audiometry for Hearing Loss in Head and Neck Cancers

Overseen By Mo Oyewole

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Cisplatin

Disqualifiers: Profound hearing loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Varies based on individual treatment plans

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how offering hearing tests closer to home or remotely affects monitoring for hearing loss in people with head and neck squamous cell cancer. The focus is on patients receiving cisplatin chemotherapy and/or radiation, treatments that can sometimes lead to hearing loss. By improving access to audiometry (hearing tests), the trial aims to catch hearing changes early, potentially allowing for treatment adjustments to prevent further loss. It suits patients with head and neck cancer undergoing these specific treatments. As an unphased trial, it provides patients the opportunity to contribute to research that could improve hearing care accessibility and outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on monitoring hearing loss in patients receiving cisplatin and/or radiation.

What prior data suggests that remote audiometry is safe for monitoring hearing loss in head and neck cancer patients?

Research has shown that cisplatin, a common chemotherapy drug for head and neck cancer, can lead to hearing loss, significantly impacting quality of life. Studies suggest that altering the dose and frequency of administration might reduce hearing damage. For instance, administering smaller doses more frequently appears to cause less hearing loss. While cisplatin effectively combats cancer, patients should be aware of this potential side effect. Regular hearing tests are recommended to detect any changes early, allowing doctors to adjust treatment if needed to help protect hearing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to monitor hearing loss in patients with head and neck cancers undergoing chemotherapy, specifically with the drug cisplatin. Unlike traditional methods that require patients to travel to specialized centers for audiometry tests, this trial offers the option of remote audiometry, which can be done closer to home or even self-administered. This approach could make it easier for patients to regularly monitor their hearing health without the added burden of frequent travel, potentially leading to earlier detection of hearing issues and better management of side effects.

What evidence suggests that remote audiometry is effective for monitoring hearing loss in head and neck cancer patients?

Studies have shown that remote hearing tests can effectively monitor hearing loss in patients receiving treatments like cisplatin and radiation for head and neck cancers. In this trial, participants in Group II, Arm II can choose to undergo audiometry closer to home or self-administered remote audiometry at 3 and 12 months after chemotherapy and/or radiation treatment. This technology enables patients to take hearing tests closer to home or remotely, potentially encouraging more regular check-ups. Research has found that mobile hearing tests can accurately measure the quietest sounds a person can hear. Specifically, one study used an automated wireless hearing test system with cancer patients, showing promising results for tracking hearing changes. By identifying hearing loss early, doctors can adjust treatments to prevent further damage. ^{6 7 8 9 10}

Who Is on the Research Team?

Nicole C. Schmitt, MD, FACS

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy (cisplatin) and/or radiation treatment

Varies based on individual treatment plans

Regular visits for chemotherapy and/or radiation

Audiometry Monitoring

Participants undergo audiometry at baseline and at 3 and 12 months after treatment

12 months

3 visits (in-person or remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 18 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Audiometric Test
• Cisplatin

Trial Overview

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.

How Is the Trial Designed?

Group I: Group II, Arm II (close to home audiometry, remote audiometry) Experimental Treatment 2 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 Control 2 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 Control 2 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:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

In a study of 89 head and neck cancer patients treated with cisplatin, 29% experienced moderate to severe hearing loss, particularly at higher frequencies, indicating significant ototoxicity associated with this chemotherapy.

Specific genetic variants related to drug metabolism and DNA repair were found to increase the risk of ototoxicity, with some patients having up to 32 times higher odds of severe hearing loss, suggesting these genetic markers could help predict who is at greater risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Clinical Aspects and Genetic Variants with the Severity of Cisplatin-Induced Ototoxicity in Head and Neck Squamous Cell Carcinoma: A Prospective Cohort Study. Macedo, LT., Costa, EFD., Carvalho, BF., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06662058

Remote Audiometry to Monitor for Treatment-Related ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12313441/

Mobile Audiometry for Use in Ototoxicity Monitoring Programs

This scoping review examines the challenges of OMPs and evaluates the diagnostic accuracy of MA for hearing thresholds. A comprehensive search was conducted in ...

3.

withpower.com

withpower.com/trial/phase-squamous-cell-carcinoma-of-head-and-neck-2025-065ad

Remote Audiometry for Hearing Loss in Head and Neck ...

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 ...

4.

digscholarship.unco.edu

digscholarship.unco.edu/cgi/viewcontent.cgi?article=1070&context=honors

Efficacy of Automated Wireless Hearing Test System ...

Nine cancer patients were recruited for hearing testing. Hearing tests were conducted using an automated testing algorithm (WAHTS) in an open.

5.

pubs.asha.org

pubs.asha.org/doi/abs/10.1044/2021_AJA-21-00032

A Randomized Controlled Trial Using Automated ...

Predicting hearing loss after radiotherapy and cisplatin chemotherapy in patients with head and neck cancer. JAMA Otolaryngology–Head & Neck Surgery, 146(2), ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9339659/

Global burden of ototoxic hearing loss associated with ...

Platinum-based chemotherapeutic agents cisplatin and carboplatin are widely used in cancer treatment worldwide and may result in ototoxic hearing loss.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1368837525000752

Comparison of cisplatin-induced hearing loss in different ...

This study evaluated cisplatin-induced hearing loss between a long and short duration of infusion and volume of hydration schedule (DIVHS).

8.

researchprotocols.org

researchprotocols.org/2025/1/e71562

Comparative Study of the Quality of Life of Patients With ...

Secondary outcomes are the evaluation of the hearing and the tinnitus, the evaluation of the patients' satisfaction at the end of the study, and ...

9.

insight.jci.org

insight.jci.org/articles/view/196230

Lower, more frequent cisplatin dosing minimizes hearing ...

Lower, more frequent cisplatin dosing minimizes hearing loss in head and neck cancer ... data from the Enhancing Cancer Hearing Outcomes ...

10.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11564257/

Treatment-related hearing loss in weekly versus triweekly ...

Cisplatin-induced hearing loss is a common side effect in patients treated with cisplatin-based chemoradiation (CRT) for head and neck squamous cell carcinoma.