Trial Title:
ACOU085 for Hearing Loss Prevention in Testicular Cancer Patients Receiving Cisplatin
NCT ID:
NCT06521190
Condition:
Cisplatin-induced Hearing Loss
Conditions: Official terms:
Testicular Neoplasms
Hearing Loss
Deafness
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized, double-blind, and placebo-controlled multicenter split body trial
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
ACOU085 (bimokalner)
Description:
Transtympanic injection
Arm group label:
Active ear
Intervention type:
Drug
Intervention name:
Placebo
Description:
Transtympanic injection
Arm group label:
Placebo ear
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Confirmed diagnosis of testicular cancer with indication for a cis-Pt-containing
chemotherapeutic regimen according to current treatment guidelines and site-specific
tumor board recommendations
- Male adult patients at an age between 18 and 45 years
- Planned cis-Pt treatment with a cumulative dose of ≥300 mg/m2 which has to be
administered in three chemotherapeutic cycles
- Normal or not clinically relevant otoscopic findings in both ears
- Normal hearing at both ears according to current WHO criteria for air-conduction
4PTA (0.5/1/2/4 kHz; 0 to 19 dB HL; average of audiometric thresholds at 0.5/1/2/4
kHz) at baseline
- Normal hearing at both ears according to ASHA criteria with a hearing threshold at
any frequency (0.25 to 12 kHz) not exceeding 20 dB and a 4PTA (0.5/1/2/4 kHz)
showing ≤15 dB HL at baseline
- Normal distortion product oto-acoustic emissions (DPOAE) present in both ears at
baseline
- Patient shows normal results at trial start (V1) concerning heart rate (50 to 90
bpm), blood pressure (according to commonly accepted ranges), ECG (no pathological
findings), and laboratory parameters (ie, liver and renal function values not
clinically significant)
- Male patients and their female partner(s) must agree to use 2 forms of contraception
(one of which must be a barrier method) during 6 months after trial start (V1)
- Patient is cooperative, able to understand all aspects of the trial, and able to
speak German comparable to native speakers as per the investigator's discretion
- Patient has signed an approved informed consent form indicating that he understands
the purpose of and procedures required for the trial, will follow the trial-specific
measures, and is willing to participate in the trial
Exclusion Criteria:
- Suspected or diagnosed genetic predisposition to hearing loss (incl. DFNA2 rel. to
KCNQ4)
- History of middle ear pathology or surgery, otitis externa, chronic otitis media, or
recent acute otitis media (within ≤3 months)
- History of otologic surgery (excluding myringotomy tubes or simple tympanoplasty)
- Meniere's disease or secondary endolymphatic hydrops, auto immune hearing loss,
inner ear pathology, fluctuating hearing loss, perilymph fistula, cochlear
baro-trauma, radiation-induced hearing loss, retro-cochlear lesion, severe
tympanosclerosis, atrophic tympanic membrane
- Hearing loss of >45 dB averaged at 6 and 8 kHz in either ear
- Sudden hearing loss or conductive hearing loss >10 dB at two frequencies in either
ear
- Asymmetry in hearing thresholds between left and right ear ≥20 dB at any single
frequency or ≥10 dB at any 3 consecutive frequencies ≤ 8 kHz
- Intake of any ototoxic drugs other than the intended cis-Pt-containing
chemotherapeutic drug regimen prior to start of the trial and during the trial
period
- Previous radiation exposure >35 Gray to complete or parts of the cochlea
- Severe concomitant diseases such as heart failure (NYHA II-IV), COPD, bronchial
asthma, ongoing malignancies other than testicular cancer, auto-immune or
chronic-inflammatory diseases, endocrinological diseases, advanced hepatic or renal
failure, and primary complaint of tinnitus
- Planned consumption of medications, herbal preparations, and specific food
ingredients to treat hearing problems and/or tinnitus during the trial period
- Hypersensitivity against any primary or secondary ingredient of IMP/Placebo
medication
- Male patients with female partners who are pregnant or planning to become pregnant
during 6 months after trial start (V1)
- Use of any other investigational medicinal product (IMP) within five times the
half-life of that IMP/relevant metabolites or one month (whichever is longer) prior
to screening and planned use during the trial or up to 30 days after trial
completion
- Patient has any dependent relationship or employment status with respect to the
trial site, the sponsor, the investigator, or any supervisor
Gender:
Male
Gender based:
Yes
Gender description:
Patients with testicular cancer
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dept. of Otolaryngology - Head and Neck Surgery, Tuebingen University
Address:
City:
Tuebingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Sven Becker, PD Dr.
Facility:
Name:
Dept. of Otolaryngology - Head and Neck Surgery, Dresden University
Address:
City:
Dresden
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Marie-Luise Polk, Dr.
Facility:
Name:
Dept. of Otolaryngology - Head and Neck Surgery, Essen University
Address:
City:
Essen
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Diana Ahrweiler-Harbeck, Prof. Dr.
Facility:
Name:
Department of Otolaryngology - Head and Neck Surgery, Hamburg University
Address:
City:
Hamburg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Mark Praetorius, Prof. Dr.
Facility:
Name:
Dept. of Otolaryngology - Head and Neck Surgery, Jena University
Address:
City:
Jena
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Orlando Guntinas-Lichius, Prof. Dr.
Facility:
Name:
Dept. of Otolaryngology - Head and Neck Surgery, Mannheim University
Address:
City:
Mannheim
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Angela Schell, Prof. Dr.
Facility:
Name:
Dept. of Otolaryngology - Head and Neck Surgery, Marburg University
Address:
City:
Marburg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Wieland Behr, Dr.
Facility:
Name:
Dept. of Hematology and Oncology, Rotkreuzklinikum Munich
Address:
City:
Munich
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Marcus Hentrich, Prof. Dr.
Facility:
Name:
Dept. of Otolaryngology - Head and Neck Surgery, Munich Technical University
Address:
City:
Munich
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Markus Wirth, PD Dr.
Facility:
Name:
Dept. of Otolaryngology - Head and Neck Surgery, Wuerzburg University
Address:
City:
Wuerzburg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Till Meyer, PD Dr.
Start date:
December 15, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Acousia Therapeutics GmbH
Agency class:
Industry
Source:
Acousia Therapeutics GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06521190
