Cisplatin-related Hearing LossPhase 3SOUNDNCT07281508
Transtympanic STS Against Cisplatin-induced SNHL: the SOUND Trial
A Phase 3 study testing Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate in people with Cisplatin-related Hearing Loss, run by The Netherlands Cancer Institute at 5 sites in Netherlands.
Trial summary
The goal of this clinical trial is to learn if transtympanic sodium thiosulfate (STS) injections can prevent hearing loss caused by cisplatin chemotherapy in adults with head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cisplatin-related Hearing Loss
- What is being tested?
- Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesNetherlands
- Study dates
- 14 Aug 2025to 23 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological proof of solid head and neck malignancies with an indication for treatment with cisplatin in a cumulative dose of ≥ 200mg/m2 given in a weekly schedule of 7 times 40 mg/m2 or a 3-weekly schedule of 3 times 100 mg/m2
- Treatment with high-dose cisplatin (cumulative dose ≥ 200mg/m2) of maximum 7 cycles
- Able and willing to give written informed consent;
- WHO performance status of 0, 1 or 2;
- Age older than 18 years.
Who cannot join
- Asymmetric hearing capacity (SNHL) prior to treatment, defined as a difference between both ears in hearing capacity of ≥ 10 dB averaged over 3 adjacent frequencies in the range of 0.5 to 12.5 kHz (i.e. 0.5, 1, 2, 4, 8, 10 and 12.5 kHz).
- Baseline hearing: more than 40 dB SNHL at PTA 1-2-4 kHz (in one or both ears)
- A planned radiation dose of > 30 Gy to the cochlea (8);
- Known hypersensitivity to STS-containing HYA gel formulation;
- Any condition that would, according to the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures;
- Otologic pathology that hampers the transtympanically applied STS gel to diffuse through the round window, e.g. otosclerosis, a narrow ear canal, otitis media with effusion.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Antoni van Leeuwenhoek
Amsterdam, North Holland, 1066CX
Daniël Griffioen, MD, +31205129111, da.griffioen@nki.nl
Jeany Rademaker-Lakhai, PhD, +31205129111, j.lakhai@nki.nl
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Jeroen Jansen, Prof., +31715269111, J.c.jansen@lumc.nl
Jeroen Jansen, Prof.
- Not yet recruiting
Stichting Radboud University Medical Center
Nijmegen, 6525GA
Froukje Cals, Dr., +31243611111, Froukje.Cals@radboudumc.nl
Froukje Cals, Dr.
- Not yet recruiting
Erasmus Universitair Medisch Centrum Rotterdam
Rotterdam, South Holland, 3015GD
Stijn Keereweer, Dr., +31107040704, s.keereweer@erasmusmc.nl
Stijn Keereweer, Dr.
- Not yet recruiting
University Medical Center Utrecht
Utrecht, Utrecht, 3584CX
Robert Stokroos, Prof., +31887555555, R.J.Stokroos@umcutrecht.nl
Robert Stokroos, Prof.
About this study
Official title: Transtympanic Sodium Thiosulfate to Prevent Cisplatin-related Hearing Loss A Randomized Controlled Multicenter Phase III Trial; The SOUND Trial
The goal of this clinical trial is to learn if transtympanic sodium thiosulfate (STS) injections can prevent hearing loss caused by cisplatin chemotherapy in adults with head and neck cancer. The main question it aims to answer is:
Researchers will compare the ear treated with STS gel to the untreated ear within the same patient to see if STS prevents hearing loss.
Read more
Participants will:
- Receive STS gel injections into the middle ear of one ear (randomized) within 3 hours before each cisplatin infusion (3-7 injections per patient).
- Undergo hearing tests at baseline and 2-4 months after the last cisplatin treatment.
- Complete questionnaires about hearing and tinnitus at baseline and 2-4 months after treatment.
Read the detailed description
Trial design:
This study is an investigator-initiated randomized controlled multicenter phase III trial. Patient accrual and treatment (treatment and hearing analysis will take 22 weeks per patient) will start in 2025 and will be completed in 2028. Afterwards, the patients will have a routine follow-up for a median of 2 years to collect necessary survival data (2025-2030).
Trial population:
A hundred patients with solid head and neck malignancies who are treated with ≥ 200 mg/m2 cisplatin will be included. To be eligible for participation, patients must be 18 years or older. Study participation is not possible if more than 30 gray radiotherapy is applied to the inner ear, asymmetric hearing loss or more than 40 dB hearing loss is detected before start of treatment, known hypersensitivity to STS injections, and/or if patients have ear conditions that prevent middle ear injections from being administered properly.
Interventions:
Patients will be treated with an STS injection in one ear and no treatment in the contralateral ear. The ear to be treated with STS gel will be determined by randomization. The hearing of the treated ear will then be compared with the untreated ear. The audiometrist who conducts the hearing test will not know which ear has been treated with sodium thiosulfate. Hence, the design of this trial takes advantage of the fact that every patient has two ears, and offers the unique concept of having a randomized controlled comparison of platinum-induced hearing loss of the treated versus the untreated ear within individual patients. This results in the advantage that during the analysis of the results differences between patients are eliminated. The STS gel will be injected into the middle ear within three hours before each cisplatin infusion (range 3-7 injections per patient) into one ear, the other ear will be left untreated. Hearing tests will be conducted at baseline (before the first cisplatin therapy) and 3 months (range 2 - 4) after the last cisplatin infusion. Questionnaires will be filled in to document hearing-related complaints at baseline and 3 months (range 2 - 4) after the last cisplatin treatment. For the survival analysis on a median of 1 and 2 years after treatment, survival data will be collected from the patient's medical records. These data will be compared to similar patients from historical data. In a pilot of 10 patients in the LUMC vestibular testing will be performed at baseline and 6 weeks after the last cisplatin infusion.
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks:
Based on the results of our successfully completed phase I study, we expect that 30-50% of patients will experience a noticeable difference between the STS-treated and untreated ear (2). The STS injections in the middle ear carry small risk. Our phase 1 study has shown that administrations of sodium thiosulfate are safe. The possible risks/side effects of the injections are pain, temporary fullness in the ear, temporary dizziness, and temporary decreased hearing. There is also a very small (<1%) risk of permanent perforation of the eardrum. The injections will be given before every cisplatin treatment because sodium thiosulfate remains available in the middle and inner ear for only a temporary period. The METC does not agree with the use of a placebo control, as the risk of a complication (albeit small) is not acceptable. The current standard of care is 'no treatment' and the audiogram provides a sufficiently objective measurement. Therefore, the study design is changed to a non-placebo randomised controlled trial and only the audiometrist is blinded.
- Conditions
- Cisplatin-related Hearing Loss
- Being tested
- Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronateDrug
The transtympanic injection gel is composed of the following components:
- Sodium Thiosulfate 250mg/mL, 10mL for injection (STS)
- BiolevoxTM HA 2,2%, 2mL, pre-filled syringe for intraarticular injection (HYA)
- Sterile Phosphate-buffered Sodium Chloride, 500mL (PBS)
| Study group | Role | What they receive |
|---|---|---|
| Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate | Experimental | One ear of a patient: The transtympanic sodium thiosulphate is administered into one ear of a patient. The intervention takes place within 3 hours before each cisplatin course. The intervention takes place 3 to 7 times, depending on the cisplatin schedule Receives: Drug: Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate |
| Untreated ear | No intervention | The other ear of the same patient is left untreated |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy (clinically relevant benefit) of transtympanic STS 0.1M/0.5 HYA against platinum-related ototoxicity.
The percent of patients with a clinically relevant benefit of transtympanic STS injection against CIHL, defined as the change in the threshold between baseline and 3 months after treatment differs by ≥ 10 dB at any three adjacent frequencies from 0.5 to 16 kHz in favour of the STS treated ear.
Measured: Baseline and 2-4 months after last cycle of chemotherapy
Secondary outcomes (7)
The superiority of STS versus untreated ear with regard to hearing capacity based on audiometry.
Mean difference between STS- and untreated ears in threshold shift (post-treatment minus baseline hearing, in a continuous scale) at sensorineural pure tone averages (PTA) 1-2-4 kHz and 8-10-12.5 kHz in dB.
Measured: Baseline and 2-4 months after last cycle of chemotherapy
The superiority of STS versus untreated ear with regard to hearing loss based on American Speech-Language-Hearing Association criteria (ASHA).
The difference in sensorineural hearing loss between STS- and placebo-treated ears based on the ASHA criteria:
- Grade A: threshold shift ≥ 20 dB at any one test frequency;
- Grade B: threshold shift ≥ 10 dB at 2 consecutive frequencies;
- Grade C: loss of response at three consecutive test frequencies where responses were previously obtained (this refers specifically to the highest frequencies tested, where earlier responses are obtained close to the limits of the audiometric output and later responses cannot be obtained at the limits of the audiometer).
Measured: Baseline and 2-4 months after last cycle of chemotherapy
The superiority of STS versus untreated ear with regard to hearing loss based on TUNE criteria.
The difference in sensorineural hearing loss between STS- and placebo-treated ears based on the TUNE criteria:
- Grade 0: No hearing loss
- Grade 1a: threshold shift ≥ 10dB at PTA 8-10-12.5 kHz OR subjective hearing changes without threshold shift
- Grade 1b: threshold shift ≥ 10dB at PTA 1-2-4 kHz
- Grade 2a: threshold shift ≥ 20dB at PTA 8-10-12.5 kHz
- Grade 2b: threshold shift ≥ 20dB at PTA 1-2-4 kHz
- Grade 3: Hearing level ≥ 35dB HL at PTA 1-2-4 kHz de novo
- Grade 4: Hearing level ≥ 70dB HL at PTA 1-2-4 kHz de novo
Measured: Baseline and 2-4 months after last cycle of chemotherapy
The superiority of STS versus placebo-treated ear with regard to hearing loss based on the Common Terminology Criteria for Adverse Eventes (CTCAE) criteria.
The difference in sensorineural hearing loss between the STS- and placebo treated ears based on the CTCAE criteria (40):
- Grade 1: threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear OR subjective change in hearing in the absence of documented hearing loss;
- Grade 2: threshold shift of > 25 dB averaged at 2 contiguous test frequencies in at least one ear;
- Grade 3: threshold shift of > 25 dB averaged at 3 contiguous test frequencies in at least one ear OR hearing aid or intervention indicated
- Grade 4: Decrease in hearing to profound bilateral loss (absolute threshold > 80 dB HL at 2 kHz and above); non-serviceable hearing
Measured: Baseline and 2-4 months after last cycle of chemotherapy.
Survival
Disease-specific survival, recurrence-free and overall survival measured at median 1 and 2 years after the start of treatment.
Measured: 1 and 2 years after the start of treatment.
Quality of life/Patient-related outcome measures (PROM). Subjective hearing loss after platinum treatment.
For the evaluation of patient reported outcome measurements concerning hearing loss, we use the following questionnaire:
Speech, Spatial and Qualities of Hearing scale (SSQ) 12. This questionnaire
Each item on the questionnaire (12 questions) shows a ruler with a 10-point scale on which the responders can rate themselves. The left hand-end, or lowest grade, of the ruler represents the complete inability or complete absence of a quality, whereas the right hand represents the complete ability or complete presence of a quality.
Measured: Baseline and 2-4 months after last cycle of chemotherapy
Quality of life/Patient-related outcome measures (PROM). Subjective tinnitus after platinum treatment.
For the evaluation of patient reported outcome measurements concerning potential development of tinnitus, we use the following questionnaire:
Tinnitus Handicap Inventory (THI)-12.
The THI (12 questions) scores different degrees of severity of tinnitus, i.e. slight, mild, moderate and severe, which depends on the score obtained from the responder's answers on the questionnaire.
Measured: Baseline and 2-4 months after last cycle of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start14 Aug 2025
- Primary completion23 Mar 2030 (estimated)
- Study completion23 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cisplatin-related Hearing LossStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lotje Zuur, Prof. Dr., Principal investigator, AVL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281508
- Sponsor's protocol ID
- M21STS
- Acronym
- SOUND
- Status last verified
- Dec 2025
- First submitted
- 27 Jun 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For future research, other than defined in the protocol, a request for use of the data has to be performed. Only with ethical clearance by the METC or IRB NKI, an investigator will be allowed to use this data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transtympanic Sodium Thiosulfate to Prevent Cisplatin-related Hearing Loss A Randomized Controlled Multicenter Phase III Trial; The SOUND Trial
- ClinicalTrials.gov ID
- NCT07281508
- Acronym / sponsor ID
- SOUND / M21STS
- Conditions
- Cisplatin-related Hearing Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 23 Mar 2030 (estimated)
- Study completion
- 23 Mar 2030 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if transtympanic sodium thiosulfate (STS) injections can prevent hearing loss caused by cisplatin chemotherapy in adults with head and neck cancer. The main question it aims to answer is:
Researchers will compare the ear treated with STS gel to the untreated ear within the same patient to see if STS prevents hearing loss.
Participants will:
- Receive STS gel injections into the middle ear of one ear (randomized) within 3 hours before each cisplatin infusion (3-7 injections per patient).
- Undergo hearing tests at baseline and 2-4 months after the last cisplatin treatment.
- Complete questionnaires about hearing and tinnitus at baseline and 2-4 months after treatment.
Detailed description
Trial design:
This study is an investigator-initiated randomized controlled multicenter phase III trial. Patient accrual and treatment (treatment and hearing analysis will take 22 weeks per patient) will start in 2025 and will be completed in 2028. Afterwards, the patients will have a routine follow-up for a median of 2 years to collect necessary survival data (2025-2030).
Trial population:
A hundred patients with solid head and neck malignancies who are treated with ≥ 200 mg/m2 cisplatin will be included. To be eligible for participation, patients must be 18 years or older. Study participation is not possible if more than 30 gray radiotherapy is applied to the inner ear, asymmetric hearing loss or more than 40 dB hearing loss is detected before start of treatment, known hypersensitivity to STS injections, and/or if patients have ear conditions that prevent middle ear injections from being administered properly.
Interventions:
Patients will be treated with an STS injection in one ear and no treatment in the contralateral ear. The ear to be treated with STS gel will be determined by randomization. The hearing of the treated ear will then be compared with the untreated ear. The audiometrist who conducts the hearing test will not know which ear has been treated with sodium thiosulfate. Hence, the design of this trial takes advantage of the fact that every patient has two ears, and offers the unique concept of having a randomized controlled comparison of platinum-induced hearing loss of the treated versus the untreated ear within individual patients. This results in the advantage that during the analysis of the results differences between patients are eliminated. The STS gel will be injected into the middle ear within three hours before each cisplatin infusion (range 3-7 injections per patient) into one ear, the other ear will be left untreated. Hearing tests will be conducted at baseline (before the first cisplatin therapy) and 3 months (range 2 - 4) after the last cisplatin infusion. Questionnaires will be filled in to document hearing-related complaints at baseline and 3 months (range 2 - 4) after the last cisplatin treatment. For the survival analysis on a median of 1 and 2 years after treatment, survival data will be collected from the patient's medical records. These data will be compared to similar patients from historical data. In a pilot of 10 patients in the LUMC vestibular testing will be performed at baseline and 6 weeks after the last cisplatin infusion.
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks:
Based on the results of our successfully completed phase I study, we expect that 30-50% of patients will experience a noticeable difference between the STS-treated and untreated ear (2). The STS injections in the middle ear carry small risk. Our phase 1 study has shown that administrations of sodium thiosulfate are safe. The possible risks/side effects of the injections are pain, temporary fullness in the ear, temporary dizziness, and temporary decreased hearing. There is also a very small (<1%) risk of permanent perforation of the eardrum. The injections will be given before every cisplatin treatment because sodium thiosulfate remains available in the middle and inner ear for only a temporary period. The METC does not agree with the use of a placebo control, as the risk of a complication (albeit small) is not acceptable. The current standard of care is 'no treatment' and the audiogram provides a sufficiently objective measurement. Therefore, the study design is changed to a non-placebo randomised controlled trial and only the audiometrist is blinded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate | Experimental | Drug: Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronateOne ear of a patient: The transtympanic sodium thiosulphate is administered into one ear of a patient. The intervention takes place within 3 hours before each cisplatin course. The intervention takes place 3 to 7 times, depending on the cisplatin schedule |
| Untreated ear | No intervention | –The other ear of the same patient is left untreated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological or cytological proof of solid head and neck malignancies with an indication for treatment with cisplatin in a cumulative dose of ≥ 200mg/m2 given in a weekly schedule of 7 times 40 mg/m2 or a 3-weekly schedule of 3 times 100 mg/m2
- Treatment with high-dose cisplatin (cumulative dose ≥ 200mg/m2) of maximum 7 cycles
- Able and willing to give written informed consent;
- WHO performance status of 0, 1 or 2;
- Age older than 18 years.
Key exclusion criteria (6 listed)
- Asymmetric hearing capacity (SNHL) prior to treatment, defined as a difference between both ears in hearing capacity of ≥ 10 dB averaged over 3 adjacent frequencies in the range of 0.5 to 12.5 kHz (i.e. 0.5, 1, 2, 4, 8, 10 and 12.5 kHz).
- Baseline hearing: more than 40 dB SNHL at PTA 1-2-4 kHz (in one or both ears)
- A planned radiation dose of > 30 Gy to the cochlea (8);
- Known hypersensitivity to STS-containing HYA gel formulation;
- Any condition that would, according to the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronateThe transtympanic injection gel is composed of the following components: * Sodium Thiosulfate 250mg/mL, 10mL for injection (STS) * BiolevoxTM HA 2,2%, 2mL, pre-filled syringe for intraarticular injection (HYA) * Sterile Phosphate-buffered Sodium Chloride, 500mL (PBS) | Drug | Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate |
Primary outcome
The efficacy (clinically relevant benefit) of transtympanic STS 0.1M/0.5 HYA against platinum-related ototoxicity.
Time frame: Baseline and 2-4 months after last cycle of chemotherapy
The percent of patients with a clinically relevant benefit of transtympanic STS injection against CIHL, defined as the change in the threshold between baseline and 3 months after treatment differs by ≥ 10 dB at any three adjacent frequencies from 0.5 to 16 kHz in favour of the STS treated ear.
7 secondary outcomes
The superiority of STS versus untreated ear with regard to hearing capacity based on audiometry.
Time frame: Baseline and 2-4 months after last cycle of chemotherapy
The superiority of STS versus untreated ear with regard to hearing loss based on American Speech-Language-Hearing Association criteria (ASHA).
Time frame: Baseline and 2-4 months after last cycle of chemotherapy
The superiority of STS versus untreated ear with regard to hearing loss based on TUNE criteria.
Time frame: Baseline and 2-4 months after last cycle of chemotherapy
The superiority of STS versus placebo-treated ear with regard to hearing loss based on the Common Terminology Criteria for Adverse Eventes (CTCAE) criteria.
Time frame: Baseline and 2-4 months after last cycle of chemotherapy.
Survival
Time frame: 1 and 2 years after the start of treatment.
Quality of life/Patient-related outcome measures (PROM). Subjective hearing loss after platinum treatment.
Time frame: Baseline and 2-4 months after last cycle of chemotherapy
Quality of life/Patient-related outcome measures (PROM). Subjective tinnitus after platinum treatment.
Time frame: Baseline and 2-4 months after last cycle of chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Yes. For future research, other than defined in the protocol, a request for use of the data has to be performed. Only with ethical clearance by the METC or IRB NKI, an investigator will be allowed to use this data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lotje Zuur, Prof. Dr. principal investigator
AVL
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transtympanic sodium thiosulphate (STS) 0.1M/0,5% hyaluronate in people with Cisplatin-related Hearing Loss, run by The Netherlands Cancer Institute at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniël Griffioen, MD (+31205129111, da.griffioen@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy (clinically relevant benefit) of transtympanic STS 0.1M/0.5 HYA against platinum-related ototoxicity. (time frame: Baseline and 2-4 months after last cycle of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.