RecruitingPHASE2INTERVENTIONAL

ACOU085 for Hearing Loss Prevention in Testicular Cancer Patients Receiving Cisplatin

This study is looking into a new medicine called ACOU085, which aims to prevent hearing loss in men receiving a specific chemotherapy drug called cisplatin for testicular cancer. Cisplatin can sometimes damage hearing, and researchers want to find a way to protect against this side effect. In this study, some people will receive ACOU085 directly into one ear, and a dummy treatment (placebo) into the other ear. This allows doctors to compare how well ACOU085 works against no treatment in the same person. The study will also check if the treatment is safe and easy to tolerate. This is a Phase IIa trial, which means it’s still in the early stages of testing.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Acousia Therapeutics GmbH

Enrolment target

Start

15 Dec 2023

Estimated completion

30 Sep 2025

Cisplatin-induced Hearing Loss

What is this study about?

When men are treated for testicular cancer, a common and effective chemotherapy drug used is called cisplatin. While cisplatin is very good at fighting cancer, it can sometimes cause a side effect where it damages hearing. This type of hearing loss is called sensorineural hearing loss (SNHL).

This study is investigating a new medicine, ACOU085, to see if it can help prevent this hearing damage. The medicine will be given directly into the middle ear through a small injection. Imagine it like a targeted treatment designed to protect your hearing while you're undergoing necessary cancer care.

The main goals of this study are to find out if ACOU085 can effectively protect hearing, if it's safe to use, and if people can tolerate it well. By participating, you could help doctors understand how to better protect the hearing of future cancer patients.

Key takeaways

This study aims to prevent hearing loss caused by cisplatin chemotherapy.
ACOU085 is an experimental drug given by injection directly into the ear.
It's for men aged 18-45 with testicular cancer needing specific chemotherapy.
Participation involves regular clinic visits and hearing checks.
One ear will receive the active drug, the other a dummy treatment (placebo).
Your safety and hearing will be closely monitored throughout.

Who may be eligible?

This study is looking for men, aged 18 to 45, who have been diagnosed with testicular cancer. You must be planning to have a specific type of chemotherapy that includes a drug called cisplatin, and your doctors must recommend this treatment.

To join, your hearing must be completely normal in both ears before the study starts, and you shouldn't have any current ear infections or a past history of certain ear surgeries or problems. Your general health, including your heart, liver, and kidney function, also needs to be normal. You and your partner would need to agree to use two forms of contraception during and for six months after the study. You also need to be able to understand all the study information and speak German fluently.

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.

Are you a man aged between 18 and 45?
Do you have testicular cancer and are you due to have cisplatin chemotherapy?
Do you have normal hearing in both ears and no recent ear infections?
Are you able to speak and understand German clearly?
Are you willing to use contraception during and after the study if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study treatment, ACOU085, or a placebo (dummy drug) directly into your middle ear. This involves three separate injections into each ear, given before each of your planned chemotherapy cycles. One ear will receive the active drug, and the other will receive the placebo, allowing for a direct comparison within you.

Throughout the study, you'll have regular check-ups, including detailed hearing tests, to monitor your hearing, and other medical tests to ensure your safety. The total duration of your participation will depend on your chemotherapy schedule, but it will involve several visits to the clinic for assessments and treatments. You'll be closely monitored by the study team.

Potential risks and benefits

Taking part in this study could potentially benefit you by protecting your hearing from the side effects of cisplatin chemotherapy. However, there's no guarantee the treatment will work. As with any medical procedure or medication, there are potential risks, such as discomfort from the ear injections or side effects from the study drug, although these will be carefully monitored. You will be fully informed about all known risks before joining. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Dept. of Otolaryngology - Head and Neck Surgery, Tuebingen University
Verified postcode
Tübingen, Germany· Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Dresden University
Verified postcode
Dresden, Germany· Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Essen University
Verified postcode
Essen, Germany· Recruiting
Department of Otolaryngology - Head and Neck Surgery, Hamburg University
Verified postcode
Hamburg, Germany· Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Jena University
Verified postcode
Jena, Germany· Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Mannheim University
Verified postcode
Mannheim, Germany· Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Marburg University
Verified postcode
Marburg, Germany· Recruiting
Dept. of Hematology and Oncology, Rotkreuzklinikum Munich
Verified postcode
Munich, Germany· Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Munich Technical University
Verified postcode
Munich, Germany· Recruiting
Dept. of Otolaryngology - Head and Neck Surgery, Wuerzburg University
Verified postcode
Würzburg, Germany· Recruiting

Common questions

What is cisplatin?

Cisplatin is a strong chemotherapy drug used to treat certain cancers, including testicular cancer. While it works well, it can sometimes cause hearing problems.

What is ACOU085?

ACOU085 is an experimental medicine being tested to see if it can protect hearing from the damage that cisplatin chemotherapy might cause.

Will I know if I'm getting the real drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which ear gets ACOU085 and which gets the placebo until the study is over. This helps ensure fair results.

Why will one ear get the drug and the other a placebo?

This 'intra-individual control' helps doctors compare the effects of ACOU085 directly within the same person, making the study results more reliable.

How is ACOU085 given?

It's given through a small injection directly into the middle ear (behind the eardrum), three times in total, each time before your scheduled chemotherapy.

How to find out more

Tim P Boelke, MD

boelke@acousia.com +491705670279 Official trial record

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