Not yet recruitingOBSERVATIONAL

Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer

This study is designed to understand how a chemotherapy drug called cisplatin, often used for head and neck cancer, can affect your hearing and balance. We want to find out how often these problems occur and the best ways to screen for them during and after treatment. Researchers will compare people who receive cisplatin with those who only have radiotherapy. All participants will have regular hearing and balance tests. We're also looking into whether certain genes might make some people more likely to experience these side effects. The goal is to improve care for people undergoing treatment for head and neck cancer.

At a glance

Status

Not yet recruiting

Sponsor

Simon Jäger

Enrolment target

Start

01 Jul 2025

Estimated completion

01 Jun 2027

Ototoxic Hearing Loss Ototoxicity, Drug-Induced Cisplatin-induced Hearing Loss Cisplatin Ototoxicity Head and Neck Cancer Dizzyness Inner Ear Hearing Loss Vestibular Disease Squamous Cell Carcinoma of the Head and Neck Deafness Hearing Loss

What is this study about?

This research study is looking into a common chemotherapy drug called cisplatin, which is used to treat head and neck cancer. While cisplatin is very effective against cancer, it can sometimes cause side effects, particularly affecting your hearing and balance. This study aims to understand these side effects better.

The main goals are to find out how often hearing and balance problems occur in people treated with cisplatin and to discover the best ways to check for these issues. Researchers will compare two groups of patients: those receiving cisplatin alongside radiotherapy, and those receiving only radiotherapy. This comparison will help us understand the specific impact of cisplatin.

Ultimately, by understanding which patients are at risk and how best to monitor for these side effects, doctors hope to develop better strategies to protect patients' hearing and balance during and after cancer treatment. This could lead to improved quality of life for people undergoing head and neck cancer therapy.

Key takeaways

Study aims to understand cisplatin's effects on hearing and balance.
Compares patients receiving cisplatin with those having only radiotherapy.
Involves regular hearing and balance tests.
Seeks to find better ways to monitor for these side effects.
Optional genetic tests to identify people at higher risk.
Findings could improve future care for cancer patients.

Who may be eligible?

To join this study, you need to have a type of cancer called head and neck squamous cell carcinoma. You must be planned to have treatment with cisplatin chemotherapy and radiotherapy, or just radiotherapy. You also need to be aged between 18 and 85 years old and be willing to take part and follow the study instructions.

However, some things would mean you can't join. If you already have severe hearing loss in both ears, a cochlear implant, or have reported problems with ringing in your ears (tinnitus) or dizziness in the last three months, you might not be able to participate. Also, if you've been taking certain medications known to affect hearing, such as some water pills (diuretics) or specific antibiotics called aminoglycosides, in the last three months, you wouldn't be able to join.

Finally, if you have current severe mental health conditions or addiction problems, you would not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have head and neck cancer?
Am I aged between 18 and 85?
Am I planned to have cisplatin with radiotherapy, or radiotherapy only?
Do I have severe hearing loss in both ears already?
Have I had ringing in my ears or dizziness in the last 3 months?
Am I taking medications known to affect hearing (like certain diuretics or antibiotics)? (Check with your doctor)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll have several visits for assessments. You will undergo standard tests for your hearing, check for ringing in the ears (tinnitus), and tests to check your balance function. These tests will happen at the beginning of your treatment, at various points during your treatment, and again after your treatment has finished.

There's also an optional part of the study where researchers can look at your genes. This involves providing a sample, usually blood or saliva, to see if there are any genetic markers that might make you more likely to experience hearing problems from cisplatin. The total duration of your participation will depend on your treatment schedule and follow-up, but it will cover the period during and after your cancer treatment.

Potential risks and benefits

Participating in this study might help improve understanding of side effects from cisplatin, potentially benefiting future patients. You will also receive careful monitoring of your hearing and balance, which could help your care team spot any issues early. However, there are no direct health benefits promised to you personally. The main 'risk' is the time commitment for appointments and tests. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Klinikum Nuremberg
Verified postcode
Nuremberg, Germany

Common questions

What is cisplatin?

Cisplatin is a strong chemotherapy drug used to treat many types of cancer, including head and neck cancer.

What does 'ototoxicity' mean?

'Ototoxicity' means something that is harmful to the ear, especially hearing or balance.

Will I receive a different cancer treatment if I join?

No, you will receive the standard cancer treatment planned by your doctors; this study just adds extra checks on your hearing and balance.

What are 'vestibular problems'?

Vestibular problems relate to the inner ear system that helps you with balance, so these problems often lead to dizziness or feeling unsteady.

Is the genetic testing compulsory?

No, the genetic testing part of the study is completely optional. You can still participate in the main study without it.

How to find out more

Prof. Dr. med. Simon Jäger

simon.jaeger@klinikum-nuernberg.de +49 911-398-2822 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.