Not recruiting

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

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of hearing loss in patients with testicular cancer who are receiving a chemotherapy drug called cisplatin. The study will use a treatment known as ACOU085, which is a small molecule designed to help protect hearing. ACOU085 is administered as a thermo-reversible hydrogel through a transtympanic injection, which means it is injected directly into the ear. The trial will also include a placebo group for comparison.

The purpose of the study is to determine the safety, tolerability, and effectiveness of ACOU085 in preventing hearing loss caused by cisplatin, which is known to potentially damage hearing. Participants will receive repeated doses of ACOU085 over a period of time. The study will involve regular assessments of hearing function to monitor any changes and to compare the effects between the ear treated with ACOU085 and the ear that received the placebo.

Throughout the study, participants will undergo various hearing tests to evaluate their hearing ability, including tests for pure tone and speech recognition in both quiet and noisy environments. The study will also monitor for any side effects or adverse reactions, particularly at the injection site. The trial aims to provide valuable information on whether ACOU085 can effectively prevent hearing loss in patients undergoing treatment with cisplatin for testicular cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will undergo an initial assessment to confirm eligibility. This includes a diagnosis of testicular cancer and a planned treatment with a specific chemotherapy regimen.
The patient must have normal hearing and meet other health criteria, such as normal heart rate and blood pressure.
Step 2
Baseline assessment
A baseline assessment will be conducted to evaluate hearing and other health parameters. This includes tests for hearing thresholds and otoacoustic emissions.
The patient will also undergo a physical examination and laboratory tests to ensure all health parameters are within normal ranges.
Step 3
Administration of treatment
The patient will receive a transtympanic injection of either the study medication, ACOU085, or a placebo. This is a gel-like substance injected into the ear.
The treatment is administered in repeated doses throughout the chemotherapy cycles.
Step 4
Monitoring and follow-up
The patient's hearing and health will be monitored regularly. This includes hearing tests and assessments of any side effects.
The monitoring will occur at various points during the chemotherapy cycles and after the treatment is completed.
Step 5
Completion of the study
At the end of the study, a final assessment will be conducted to evaluate the effectiveness of the treatment in preventing hearing loss.
The patient will receive a summary of their participation and any relevant findings related to their health.

Who can join the trial?

11 criteria

Confirmed diagnosis of testicular cancer and a need for a specific chemotherapy treatment that includes a drug called cis-Pt.
Must be a male adult between the ages of 18 and 45 years.
Planned treatment with cis-Pt, with a total dose of at least 300 mg/m², given over 3 cycles of chemotherapy.
Normal or not significant findings in ear examinations for both ears.
Normal hearing in both ears according to the World Health Organization (WHO) standards, which means hearing levels between 0 to 19 decibels (dB) at certain frequencies (0.5, 1, 2, and 4 kHz) at the start of the study.
Normal hearing in both ears according to the American Speech-Language-Hearing Association (ASHA) standards, with no hearing level exceeding 20 dB at any frequency (0.25 to 12 kHz) and an average hearing level of 15 dB or less at the specified frequencies at the start of the study.
Normal results in a test called distortion product oto-acoustic emissions (DPOAE) in both ears at the start of the study.
Normal heart rate (50 to 90 beats per minute), blood pressure within common ranges, normal ECG (a heart test), and normal liver and kidney function tests at the start of the study.
Male participants and their female partners must agree to use two forms of birth control, one being a barrier method, for 6 months after starting the study.
Must be cooperative, able to understand all parts of the study, and able to speak German fluently as determined by the study investigator.
Must have signed a consent form indicating understanding of the study's purpose and procedures, willingness to follow study-specific measures, and willingness to participate in the study.

Who cannot join the trial?

4 criteria

Patients who do not have sensorineural hearing loss (SNHL). This is a type of hearing loss that happens when there is damage to the inner ear or the nerve pathways from the inner ear to the brain.
Patients who are not male. This study is only for male participants.
Patients who are not within the specified age range. The study has a specific age range for participants.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Goethe University Frankfurt
Frankfurt, Germany
Verified
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany
Verified
Philipps-Universitaet Marburg
Marburg, Germany

Trial locations

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Investigated drugs

ACOU085
is a medication being studied for its ability to prevent hearing loss in patients with testicular cancer who are receiving treatment with cisplatin. The trial aims to assess the safety, tolerability, and effectiveness of repeated doses of ACOU085 in protecting against hearing damage caused by the cancer treatment.
Cisplatin
is a chemotherapy drug used to treat testicular cancer. It is known to be effective in fighting cancer cells but can also cause side effects, including hearing loss. This trial is investigating ways to prevent this particular side effect while patients undergo treatment with cisplatin.

Acou085

What is already known about the treatment

ACOU085 – ACOU085 is administered as repeated doses and is currently being studied in clinical trials for its potential to prevent hearing loss in patients with testicular cancer who are receiving cisplatin, a chemotherapy drug known to cause hearing damage. The medication is in the investigational stage, with ongoing research to determine its safety, tolerability, and effectiveness. It is primarily indicated for sensorineural hearing loss, particularly in the context of ototoxicity from cancer treatment. ACOU085 works by targeting molecular pathways involved in hearing function, aiming to protect the inner ear from damage. It falls under the pharmacological classification of otoprotective agents.

Investigated diseases

Sensorineural Hearing Loss – Sensorineural hearing loss is a type of hearing impairment that occurs due to damage to the inner ear or the nerve pathways from the inner ear to the brain. It often results from exposure to loud noise, aging, or certain medications that can harm the inner ear structures. This condition typically affects the ability to hear faint sounds and can make understanding speech difficult, especially in noisy environments. The progression of sensorineural hearing loss can vary, with some individuals experiencing a gradual decline in hearing ability over time. It is usually permanent, as the damaged hair cells in the cochlea or the auditory nerve do not regenerate. The severity of hearing loss can range from mild to profound, impacting daily communication and quality of life.