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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
University Hospital Jena KöR	Jena	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Aachen AöR	Aachen	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Rotkreuzklinikum Munchen gGmbH	Munich	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Uwuvhmumvopxjksqbnjdh Eagkt Axl	Essen	Germany
Uxbycebjqpzmsberziifo Mulsxwvq Ama	Munster	Germany
Gphyvg Utdllgqzhs Fdyapudcr	Frankfurt	Germany
Uykyzpczydzfatstircyd Wxuqfvleo Asc	Wuerzburg	Germany
Ucjcrycpbi Mcntyli Czpzil Heaqoebssxjppwjzn	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	30.09.2023

Trial locations

Investigated drugs:

Acou085

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.

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.

Trial ID:

2023-503696-15-00

Protocol code:

Acousia Study 02

NCT ID:

NCT06521190

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?