Actively Recruiting
ACOU085 for Hearing Loss Prevention in Testicular Cancer Patients Receiving Cisplatin
Led by Acousia Therapeutics GmbH · Updated on 2024-09-19
40
Participants Needed
10
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Randomized, double-blind, placebo-controlled, multicenter phase IIa clinical trial in adult male TCa patients with the risk to suffer from sensorineural hearing loss (SNHL) due to cisplatin therapy within a chemotherapeutic regimen of testicular cancer. Patients will have an indication for a cisplatin-containing chemotherapy according to current guidelines and trial site tumor board recommendations. The trial is designed to show efficacy, safety, and tolerability of ACOU085 administered into the middle ear using 3 transtympanic injections per ear prior to 3 planned and corresponding 3-week chemotherapeutic cycles. The intra-individual control will be done by placebo injection into the respective contralateral middle ear.
CONDITIONS
Official 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 with indication for cisplatin-containing chemotherapy as per guidelines and tumor board
- Male patients aged between 18 and 45 years
- Planned cisplatin treatment with cumulative dose of 63300 mg/m2 given in three cycles
- Normal or non-relevant otoscopic findings in both ears
- Normal hearing at both ears per WHO air-conduction 4PTA criteria at baseline (0.5/1/2/4 kHz: 0 to 19 dB HL)
- Normal hearing per ASHA criteria with thresholds not exceeding 20 dB at any frequency (0.25 to 12 kHz) and 4PTA 6315 dB HL at baseline
- Normal distortion product oto-acoustic emissions (DPOAE) present in both ears at baseline
- Normal heart rate (50 to 90 bpm), blood pressure, ECG, and lab parameters at trial start
- Male patients and female partners agree to use two contraception methods (one barrier) during 6 months after trial start
- Able to understand trial details and speak German comparable to native speakers
- Signed informed consent indicating understanding and willingness to participate
You will not qualify if you...
- Genetic predisposition to hearing loss (including DFNA2 related to KCNQ4)
- History of middle ear pathology, surgery (excluding myringotomy tubes or simple tympanoplasty), otitis externa, chronic or recent acute otitis media (within 3 months)
- Meniere's disease, autoimmune hearing loss, inner ear pathology, fluctuating hearing loss, perilymph fistula, cochlear barotrauma, radiation-induced hearing loss, retro-cochlear lesion, severe tympanosclerosis, atrophic tympanic membrane
- Hearing loss greater than 45 dB averaged at 6 and 8 kHz in either ear
- Sudden or conductive hearing loss over 10 dB at two frequencies in either ear
- Hearing asymmetry greater than 20 dB at any frequency or 10 dB at any 3 consecutive frequencies up to 8 kHz
- Use of ototoxic drugs other than planned cisplatin chemotherapy before or during trial
- Previous radiation above 35 Gray to cochlea
- Severe diseases like heart failure (NYHA II-IV), COPD, asthma, other malignancies, autoimmune or chronic inflammatory diseases, advanced liver or kidney failure, tinnitus as primary complaint
- Planned use of medications or supplements for hearing or tinnitus during trial
- Hypersensitivity to any ingredient of study medication or placebo
- Partner pregnant or planning pregnancy during 6 months after trial start
- Use of other investigational drugs within 5 half-lives or 1 month before screening and during trial
- Employment or dependent relationship with trial site, sponsor, investigator, or supervisors
AI-Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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