Ototoxic Hearing LossPhase 4NCT04226456
Intratympanic Administration of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
A Phase 4 study testing N-acetyl cysteine in people with Ototoxic Hearing Loss and Ototoxic Hearing Loss, Bilateral, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the efficacity of N-acetylcystein against Cisplatin-induced ototoxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ototoxic Hearing Loss, Ototoxic Hearing Loss, Bilateral, Ototoxicity
- What is being tested?
- N-acetyl cysteine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jul 2021to 3 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- ≥ 18-year-old
- Patients suffering from a neoplastic disease for which treatment protocol includes Cisplatin.
Who cannot join
- Women of childbearing potential pregnant or with intention to become pregnant within the trial duration
- Women who are breastfeeding
- Pathological findings on otoscopy that do not allow safe intratympanic drug delivery.
- Conductive hearing loss > 20dBHL
- Meniere disease
- Medical history of sudden hearing loss
- Sensoryneural Hearing loss (SNHL) with mean ≥ 40dbHL Pure Tonal Audiometry (PTA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
The purpose of this study is to assess the efficacity of N-acetylcystein against Cisplatin-induced ototoxicity.
Read the detailed description
This is a monocentric, randomized, controlled, open label phase IV superiority trial.
After signing the informed consent form and upon the confirmation of the patient eligibility, patients will be randomized 1:1 to the experimental arm (NAC + Cisplatin) or the standard arm (Cisplatin).
The primary objective of this trial is to evaluate the protecting effect of Lysomucil® 10% against Cisplatin-induced ototoxicity. In this case, we will evaluate its effect through the transtympanic administration in both ears.
- Being tested
- N-acetyl cysteine
- Medical subject headings
- Ototoxicity, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
Also called Lysomucil 10%
Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard arm (Arm A): Cisplatin from 70 to 100 mg/m2 intravenous (IV) once for 3 to 7 cycles +/- Radiotherapy (depending on the type and the severity of the neoplastic disease) Dosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease. |
| N-acetylcysteine | Experimental | Experimental arm (Arm B):
* 0.4 to 1 ml of NAC 10% through intratympanic injection (ITI) from 40 to 60 minutes maximum prior to each Cisplatin cycle.
* Cisplatin from 70 to 100 mg/m2 intravenous (IV) once for 3 to 7 cycles +/- Radiotherapy (depending on the type and the severity of the neoplastic disease)
Dosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease. Receives: Drug: N-acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparition of ototoxicity
the apparition of ototoxicity as defined by the International Common Terminology Criteria for Adverse Events (CTCAE), version 5:
- A Threshold shift of 15 - 25 decibel (dB) averaged at 2 contiguous test frequencies in at least one ear
- and/or the apparition of a tinnitus (not previously present).
Measured: 6 month after last injection
Secondary outcomes (3)
Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System)
the apparition of ototoxicity as defined by the International Common Terminology Criteria for Adverse Events (CTCAE), version 5:
- A Threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear
- and/or the apparition of a tinnitus (not previously present).
Measured: 6 month after last injection
Hearing quality of life: Evaluation of the Impact of Hearing Loss in Adults ERSA
Evaluation of the Impact of Hearing Loss in Adults (ERSA) For each question, the score of 0 means maximal difficulties, the sore of 10 means ideal situation Formulation is uniform, with no inversions: 0 always corresponds to maximal difficulty and 10 to an ideal situation, so that the lower the score the greater the impact of hearing loss on quality of life. Maximum score is 200 for respondents in work and 150 for those not in work or in retirement.
Measured: 6 month after last injection
Hearing quality of life: Tinnitus Handicap Index (THI)
Tinnitus Handicap Index (THI) score Range : 0 to 100. Higher scores mean a worse outcome.
Measured: 6 month after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start10 Jul 2021
- Primary completion3 May 2023
- Study completion3 Sep 2023
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ototoxic Hearing LossStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaëtan Cavelier, MD, Principal investigator, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226456
- Sponsor's protocol ID
- CHUB-NAC
- Status last verified
- Feb 2023
- First submitted
- 9 Dec 2019
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial: Intratympanic Injection of N-acetylcysteine for Protection of Cisplatin-induced Ototoxicity
- ClinicalTrials.gov ID
- NCT04226456
- Acronym / sponsor ID
- CHUB-NAC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 Sep 2023 (actual)
- First posted
- 13 Jan 2020 (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 purpose of this study is to assess the efficacity of N-acetylcystein against Cisplatin-induced ototoxicity.
Detailed description
This is a monocentric, randomized, controlled, open label phase IV superiority trial.
After signing the informed consent form and upon the confirmation of the patient eligibility, patients will be randomized 1:1 to the experimental arm (NAC + Cisplatin) or the standard arm (Cisplatin).
The primary objective of this trial is to evaluate the protecting effect of Lysomucil® 10% against Cisplatin-induced ototoxicity. In this case, we will evaluate its effect through the transtympanic administration in both ears.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard arm (Arm A): Cisplatin from 70 to 100 mg/m2 intravenous (IV) once for 3 to 7 cycles +/- Radiotherapy (depending on the type and the severity of the neoplastic disease) Dosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease. |
| N-acetylcysteine | Experimental | Drug: N-acetyl cysteineExperimental arm (Arm B): * 0.4 to 1 ml of NAC 10% through intratympanic injection (ITI) from 40 to 60 minutes maximum prior to each Cisplatin cycle. * Cisplatin from 70 to 100 mg/m2 intravenous (IV) once for 3 to 7 cycles +/- Radiotherapy (depending on the type and the severity of the neoplastic disease) Dosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 18-year-old
- Patients suffering from a neoplastic disease for which treatment protocol includes Cisplatin.
Key exclusion criteria (7 listed)
- Women of childbearing potential pregnant or with intention to become pregnant within the trial duration
- Women who are breastfeeding
- Pathological findings on otoscopy that do not allow safe intratympanic drug delivery.
- Conductive hearing loss > 20dBHL
- Meniere disease
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 |
|---|---|---|
| N-acetyl cysteineAlso: Lysomucil 10%Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears | Drug | N-acetylcysteine |
Primary outcome
Apparition of ototoxicity
Time frame: 6 month after last injection
the apparition of ototoxicity as defined by the International Common Terminology Criteria for Adverse Events (CTCAE), version 5: * A Threshold shift of 15 - 25 decibel (dB) averaged at 2 contiguous test frequencies in at least one ear * and/or the apparition of a tinnitus (not previously present).
3 secondary outcomes
Evaluate the apparition of ototoxicity defined by the inclusion of high frequency audiometry (Tune Grading System)
Time frame: 6 month after last injection
Hearing quality of life: Evaluation of the Impact of Hearing Loss in Adults ERSA
Time frame: 6 month after last injection
Hearing quality of life: Tinnitus Handicap Index (THI)
Time frame: 6 month after last injection
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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Ototoxic Hearing Loss
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. This study is not recruiting at the moment.
Gaëtan Cavelier, MD principal investigator
Centre Hospitalier Universitaire Saint Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-acetyl cysteine in people with Ototoxic Hearing Loss and Ototoxic Hearing Loss, Bilateral, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apparition of ototoxicity (time frame: 6 month after last injection). 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 24 Oct 2023.