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poor recruitment
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The purpose of this study is to assess the efficacity of N-acetylcystein against Cisplatin-induced ototoxicity.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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):
Dosis and number of Cisplatin cycles are determined by the oncologist depending on type and severity of neoplastic disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetyl cysteine | Drug | Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apparition of ototoxicity | the apparition of ototoxicity as defined by the International Common Terminology Criteria for Adverse Events (CTCAE), version 5:
| 6 month after last injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaëtan Cavelier, MD | Centre Hospitalier Universitaire Saint Pierre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Pierre | Brussels | 1000 | Belgium |
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| ID | Term |
|---|---|
| D000081015 | Ototoxicity |
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| 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. | 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. | 6 month after last injection |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D006311 | Hearing Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |