#1 Clinical Trials Search in Europe

Acou085

Clinical trials are investigating Acou085 in people with testicular cancer who are receiving cisplatin. The main goal is to see whether it can help prevent hearing loss and to check safety, tolerability, and early signs of benefit.

Table of Contents

Trial overview

The available study of Acou085 was a clinical trial in people with testicular cancer who were receiving cisplatin chemotherapy.[1] The study asked whether Acou085 could help prevent hearing loss caused by cisplatin, which is known in the trial data as ototoxic damage, meaning ear damage from a medicine.[1]

This was an interventional study, which means the researchers gave a treatment and then measured its effects.[1] The trial also looked at safety, tolerability, and early signs of benefit.[1]

Who was studied

The trial targeted patients with testicular cancer who were receiving cisplatin chemotherapy.[1] The data do not list all detailed eligibility rules, but the study population was clearly focused on this cancer treatment setting.[1]

In simple terms, the study group was made up of people at risk of hearing loss because of their cancer treatment, not people with hearing loss from any cause.[1]

What was tested

The trial compared Acou085 with a placebo, which is a look-alike treatment with no active ingredient.[1] The placebo was designed to match the study drug in appearance and size.[1]

Acou085 was given as a transtympanic injection, meaning it was injected through the eardrum into the middle ear area.[1] The trial data do not provide a broader drug description, so the focus here is only on how it was studied in this trial.[1]

What was measured

The main outcome was the proportion of patients who had a difference of at least 10 decibels between both ears in at least two hearing frequencies.[1] A decibel is a unit used to measure sound level, and a difference of 10 decibels can show a meaningful change in hearing.[1]

The hearing test used was pure tone audiometry, or PTA, which checks hearing at different pitches.[1] The trial focused on high frequencies and extended high frequencies, including 4, 6, 8, 10, 12, 14, and 16 kHz, because these can be affected early by hearing damage.[1]

Researchers compared hearing at baseline, before cisplatin started, with hearing at the end of the third chemotherapy cycle on Day 64.[1] This helped them see whether hearing changed during treatment.[1]

Trial phase and status

The study was a Phase 2 trial.[1] Phase 2 studies are used to look more closely at whether a treatment may help, while still checking safety and tolerability.[1]

The trial status is completed, and the enrollment was 40 participants.[1] This means the study was finished and the planned measurements were collected.[1]

What these results mean for patients

This research is about protecting hearing during a cancer treatment that can cause ear damage.[1] The study was designed to see whether Acou085 could reduce hearing changes in a very specific group: people with testicular cancer receiving cisplatin.[1]

The trial does not study all forms of hearing loss, and it does not describe Acou085 as a general treatment for hearing problems.[1] Instead, it focuses on one prevention question in one treatment setting, using hearing tests as the main way to judge the effect.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06521190 Phase 2 Sensorineural hearing loss prevention in testicular cancer patients receiving cisplatin Completed 40

FAQ

  • What is Acou085 being studied for? Acou085 is being studied to see if it can help prevent hearing loss caused by cisplatin chemotherapy. The trial focuses on hearing protection in patients with testicular cancer.
  • Who can take part in the trial? The trial studied patients with testicular cancer who were receiving cisplatin. The data do not list all detailed entry rules, but the target group was clearly adults in this treatment setting.
  • What phase is the Acou085 trial? The trial is a Phase 2 study. Phase 2 trials usually look more closely at whether a treatment may work and continue to monitor safety.
  • What outcome was measured? The main outcome was hearing change between the two ears, measured by hearing tests at several high frequencies. The study looked for a difference of 10 decibels or more in at least two frequencies.
  • Is the Acou085 trial finished? Yes. The trial status is completed. This means the planned study visits and measurements were finished.

Ongoing Clinical Trials on Acou085

  • Study on ACOU085 to Prevent Hearing Loss in Testicular Cancer Patients Receiving Cisplatin

    Not recruiting

    1
    Investigated drugs:
    Germany

Glossary

  • Clinical trial: A research study in people that tests a medical treatment or procedure to see if it is safe and helpful.
  • Phase 2: A mid-stage trial that looks at early signs of benefit and continues safety checks after initial testing.
  • Testicular cancer: A cancer that starts in the testicles, which are part of the male reproductive system.
  • Cisplatin: A chemotherapy drug used to treat some cancers. In this study, it is the treatment that can cause hearing damage.
  • Ototoxic damage: Damage to the ear caused by a medicine or other harmful exposure. It can lead to hearing loss.
  • Sensorineural hearing loss: Hearing loss caused by damage to the inner ear or the hearing nerve.
  • Transtympanic injection: An injection given through the eardrum into the middle ear area.
  • Placebo: A look-alike treatment with no active ingredient, used for comparison in a trial.
  • Primary outcome: The main result the researchers measure to decide whether the treatment may help.
  • Pure tone audiometry (PTA): A hearing test that checks how well a person hears tones at different pitches.
  • High frequencies: Higher-pitched sounds, often important for understanding speech clearly.
  • Extended high frequencies: Very high sound pitches beyond the usual hearing test range.

References