Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase IIa randomized, double-blind, and placebo-controlled multicenter split body trial to determine safety, tolerability, and efficacy of repeated doses of ACOU085 for the prevention of hearing loss in testicular cancer patients receiving cisplatin

This research is testing a new medicine called ACOU085. The aim is to see if it can help prevent hearing damage in men with testicular cancer who are being treated with a chemotherapy drug called cisplatin. Cisplatin can sometimes cause hearing loss, so this study hopes to find a way to stop that from happening. The study will look at how safe the new medicine is, how well people can cope with it, and if it actually helps to protect hearing. It's a 'Phase IIa' study, which means it's an earlier stage trial to gather more information on effectiveness before larger studies. Participants will receive either the active medicine or a dummy medicine (placebo) to fairly compare the results.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Acousia Therapeutics GmbH

Enrolment target

Start

28 Sep 2023

sensorineural hearing loss (SNHL)

What is this study about?

When people are treated for testicular cancer, a common and effective chemotherapy drug used is called cisplatin. While cisplatin is very good at treating cancer, a side effect for some patients can be damage to their hearing. This can sometimes lead to permanent hearing loss, especially for high-pitched sounds. This study is exploring a new medicine, which we'll call ACOU085, to see if it can protect hearing from this damage.

The main goal of this particular study is to find out if ACOU085 is safe to use, if people can take it without too many unpleasant side effects, and most importantly, if it actually helps prevent hearing loss in men receiving cisplatin. Researchers will be carefully monitoring participants' hearing throughout the study to see if the new medicine makes a difference compared to not receiving it. This is an important step towards potentially offering a better quality of life for cancer patients.

Because this is a 'Phase IIa' study, it’s an earlier stage of research. This means the researchers are looking for initial signs that the treatment is effective and gathering more information on its safety and how the body handles it. If this study shows promising results, it could lead to larger studies to confirm these findings and eventually, hopefully, to a new treatment option for patients.

Key takeaways

This study is testing a new medicine (ACOU085) to prevent hearing loss.
It's for men with testicular cancer starting cisplatin chemotherapy.
Participants will receive either the active medicine or a 'dummy' placebo.
Regular hearing tests and medical checks will be done throughout the study.
The primary goal is to assess safety, how well patients tolerate it, and if it protects hearing.
You can withdraw from the study at any time without affecting your normal care.

Who may be eligible?

To be part of this study, you need to be an adult male, at least 18 years old, and diagnosed with testicular cancer. You must be about to start chemotherapy that includes a drug called cisplatin for the first time.

There will be other specific medical requirements that your doctor will need to check. For example, your general health will need to be good enough to take part in the study, and your current hearing levels will be assessed. The study is specifically looking for men who haven't had cisplatin chemotherapy before, as the aim is to prevent hearing loss, not treat existing loss.

Your study doctor will go through all the detailed criteria with you to make sure this study is suitable for you. It's important to be open with them about your full medical history.

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 an adult male?
Are you at least 18 years old?
Do you have testicular cancer?
Are you about to start cisplatin chemotherapy for the first time?
Are you generally healthy enough for a clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new medicine, ACOU085, or a dummy medicine (placebo). The placebo looks exactly like the active medicine but contains no active ingredients. You wouldn't know which one you're getting, and neither would your study doctor, as this helps to make the trial results fair and unbiased.

You would have regular visits to the clinic throughout your chemotherapy treatment. These visits would involve careful hearing tests, including checking how well you hear different tones and how well you understand speech, both in quiet and noisy environments. Researchers would also check specific ear functions. You would also have routine medical checks like blood tests, physical examinations, and heart rhythm checks (ECGs) to make sure you are safe and that the medicine isn't causing any unexpected problems.

The main part of the study would involve monitoring your hearing and health from before you start your cisplatin chemotherapy, during your first three cycles of treatment, and for a short time after. This period is expected to last around 64 days for the main assessment, with further follow-up visits to continue monitoring your hearing and overall health.

Potential risks and benefits

Participating in a clinical trial can have potential benefits, such as contributing to medical knowledge that could help future patients and potentially receiving a new treatment that might protect your hearing. However, there are also potential risks; the new medicine might not work, it could have side effects, or it might interact with your other treatments. All known risks will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care. Before deciding, it's very important to discuss all benefits and risks with your doctor and family.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is cisplatin?

Cisplatin is a strong chemotherapy medicine used to treat certain cancers, including testicular cancer. It works by killing cancer cells.

Why is hearing loss a concern with cisplatin?

Cisplatin can sometimes damage the delicate cells in the inner ear, leading to hearing loss, especially for high-pitched sounds. This can affect daily life.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks like the real treatment but doesn't contain any active drug. It helps researchers compare the true effects of the new medicine.

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

No, in this type of study, neither you nor your doctors will know whether you are receiving the active medicine or the placebo. This is to ensure unbiased results.

What is 'Phase IIa' research?

Phase IIa is an early stage of clinical research. It focuses on finding out if a new treatment works, how safe it is, and what the right dose might be, usually in a smaller group of people.