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

Trial Summary

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 data supports the effectiveness of the drug cisplatin for hearing loss in head and neck cancers?

Research shows that cisplatin, while effective for treating head and neck cancers, can cause hearing loss (ototoxicity). Studies have found that high-frequency hearing tests can detect this hearing loss earlier than standard tests, which is important for monitoring and managing side effects. ^{1 2 3 4 5}

Is cisplatin safe for humans?

Cisplatin is a chemotherapy drug used to treat various cancers, but it can cause hearing loss (ototoxicity) in some patients. This side effect is well-documented, and healthcare providers should monitor hearing during treatment to manage any potential hearing impairment. ^{1 2 3 6 7}

What makes the drug cisplatin unique for treating hearing loss in head and neck cancers?

Cisplatin is unique because it is a chemotherapy drug that can cause hearing loss (ototoxicity), and this trial uses remote audiometry to monitor this side effect in patients with head and neck cancers. This approach aims to detect hearing changes earlier and more reliably than traditional methods, potentially improving patient outcomes. ^{1 2 3 8 9}

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.

Research Team

Nicole C. Schmitt, MD, FACS

Principal Investigator

Emory University Hospital/Winship Cancer Institute

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Audiometric test criteria in the detection of cisplatin ototoxicity. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Early detection of cisplatin ototoxicity. Selected case reports. [2019]

3. Switzerland 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. [2023]

4. Greece pubmed.ncbi.nlm.nih.gov

Hearing Loss After Cisplatin-based Chemoradiotherapy for Locally Advanced Head and Neck Cancer: A Prospective Single-institution Study. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Hearing loss due to concurrent daily low-dose cisplatin chemoradiation for locally advanced head and neck cancer. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

A Review of Cisplatin-Associated Ototoxicity. [2023]

7. India pubmed.ncbi.nlm.nih.gov

Auditory function and quality of life in patients receiving cisplatin chemotherapy in head and neck cancer: A case series follow-up study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

High-dose cisplatin treatment: hearing loss and plasma concentrations. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

[Monitoring hearing during ototoxic cisplatin therapy]. [2013]