Actively Recruiting
Phase IIa Randomized, Double-blind, Placebo-controlled Trial of ACOU085 Injections to Prevent Hearing Loss in Male Testicular Cancer Patients Receiving Cisplatin
Led by Acousia Therapeutics GmbH · Updated on 2024-09-19
40
Participants Needed
10
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates hearing loss prevention in adult male patients with testicular cancer who are scheduled to receive cisplatin-based chemotherapy. It aims to evaluate the safety, effectiveness, and tolerability of ACOU085, a drug administered directly into the middle ear to reduce the risk of sensorineural hearing loss caused by cisplatin treatment. This phase IIa, randomized, double-blind, placebo-controlled study is conducted at multiple centers and includes men aged 18 to 45 years. Participants will receive three transtympanic injections of ACOU085 into one ear and a placebo injection into the other ear before each of the three planned chemotherapy cycles, each lasting three weeks. This split-body design allows comparison of the active drug with placebo within the same patient. The injections target the round window niche of the middle ear and are scheduled to match the chemotherapy cycles. Throughout the study, participants will undergo hearing assessments including pure tone audiometry (PTA) air measurements at 9 weeks and additional tests such as distortion product otoacoustic emissions, PTA bone conduction, and speech understanding tests up to 150 days. Safety parameters like heart rate, blood pressure, ECG, and laboratory tests will be monitored. The trial runs from December 2023 to September 2025, with ongoing evaluation of hearing function and safety outcomes.
CONDITIONS
Brief Title
ACOU085 for Hearing Loss Prevention in Testicular Cancer Patients Receiving Cisplatin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of testicular cancer needing cisplatin chemotherapy per guidelines and tumor board
- Male patients aged 18 to 45 years
- Planned cisplatin treatment with at least 300 mg/m2 total dose over three chemotherapy cycles
- Normal or non-significant ear exam findings in both ears
- Normal hearing in both ears by WHO and ASHA criteria at baseline
- Normal distortion product otoacoustic emissions (DPOAE) in both ears at baseline
- Normal heart rate, blood pressure, ECG, and lab results at trial start
- Male patients and female partners agree to use two forms of contraception for six months after trial start
- Patient can cooperate, understand the trial, and speak German at native level
- Signed informed consent form indicating understanding and willingness to participate
You will not qualify if you...
- Suspected or diagnosed genetic hearing loss conditions
- History of middle ear disease, surgery, or recent ear infections within three months
- Otologic surgery history except minor procedures
- Conditions like Meniere's disease, autoimmune hearing loss, inner ear pathologies, or severe ear abnormalities
- Hearing loss over 45 dB at 6 and 8 kHz in either ear
- Sudden or conductive hearing loss over 10 dB at two frequencies
- Significant hearing asymmetry between ears
- Use of ototoxic drugs other than planned cisplatin chemotherapy
- Previous cochlear radiation exceeding 35 Gray
- Severe diseases such as heart failure, COPD, asthma, other cancers, autoimmune or chronic inflammatory diseases, endocrine disorders, advanced liver or kidney failure, or tinnitus as primary complaint
- Planned use of medications or supplements for hearing or tinnitus during trial
- Allergy to study drug or placebo ingredients
- Male patients with pregnant or planning-to-be-pregnant female partners during six months after trial start
- Use of other investigational drugs recently or planned during the trial
- Any employment or dependent relationship with the trial team or sponsor
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of three chemotherapy cycles totaling at least 300 mg/m2 cisplatin
Participants receive transtympanic injections of either ACOU085 or placebo to prevent hearing loss during cisplatin chemotherapy.
Multiple injections aligned with chemotherapy cycles
Duration - Up to 150 days after treatment
Participants are monitored for hearing outcomes and safety after completing treatment.
Visits at 9 weeks and approximately 150 days
Trial Site Locations
Total: 10 locations
1
Dept. of Otolaryngology - Head and Neck Surgery, Tuebingen University
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
2
Dept. of Otolaryngology - Head and Neck Surgery, Dresden University
Dresden, Germany
Actively Recruiting
3
Dept. of Otolaryngology - Head and Neck Surgery, Essen University
Essen, Germany
Actively Recruiting
4
Department of Otolaryngology - Head and Neck Surgery, Hamburg University
Hamburg, Germany
Actively Recruiting
5
Dept. of Otolaryngology - Head and Neck Surgery, Jena University
Jena, Germany
Actively Recruiting
6
Dept. of Otolaryngology - Head and Neck Surgery, Mannheim University
Mannheim, Germany
Actively Recruiting
7
Dept. of Otolaryngology - Head and Neck Surgery, Marburg University
Marburg, Germany
Actively Recruiting
8
Dept. of Hematology and Oncology, Rotkreuzklinikum Munich
Munich, Germany
Actively Recruiting
9
Dept. of Otolaryngology - Head and Neck Surgery, Munich Technical University
Munich, Germany
Actively Recruiting
10
Dept. of Otolaryngology - Head and Neck Surgery, Wuerzburg University
Würzburg, Germany
Actively Recruiting
Research Team
T
Tim P Boelke, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Frequently Asked Questions
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