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| Name | Class |
|---|---|
| Toronto Sunnybrook Regional Cancer Centre | OTHER |
| London Regional Cancer Program, Canada | OTHER |
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Although many intratympanic agents have been attempted, N-Acetylcysteine (NAC) appears to be the most promising and is a powerful, commonly used anti-oxidant. The goal of this prospective phase 2 randomized controlled trial is to determine the optimal dosage and effectiveness of intratympanic NAC injection in reducing hearing loss in head & neck cancer patients receiving cisplatin chemotherapy with curative intent.
A prospective randomized controlled trial phase 1 using a standard 3+3 design, followed by a randomized controlled phase 2 to determine dosage, safety, and efficacy of intratympanic NAC to treat hearing loss in head & neck patients receiving high-dose cisplatin chemotherapy. Participants will complete various pre-treatment hearing tests. One ear will be randomly chosen for the experimental treatment and the other ear will serve as the control ear. Participants will receive intratympanic NAC injections 60 minutes prior to their scheduled chemotherapy sessions in the experimental ear. The control ear will not receive any injection. Follow up hearing tests will be performed 2 months following completion of their primary cancer treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm with Intratympanic NAC injection | Active Comparator | One ear will be randomly chosen for the experimental treatment and receive intratympanic NAC injections 60 minutes prior to their scheduled chemotherapy sessions |
|
| Control arm with No injection | No Intervention | The control ear will not receive any injections |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Acetyl Cysteine | Drug | One ear will be randomly chosen for the experimental treatment of intratympanic NAC. The other ear will serve as the control ear which will not receive any injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of a safe and tolerable dosage for intratympanic NAC injection | The primary end-point of the phase 1 part of this study is the safety and tolerability of intratympanic NAC injections, by determining the causality of adverse events and serious adverse events and grading according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 | Within 1 day |
| Improvement in hearing threshold with intratympanic NAC injection | The primary outcome measure of this study will be a comparison of hearing loss between the control and NAC-injected ears. More specifically, each ear will be scored as having hearing loss if there is a greater than 10dB hearing loss in three contiguous frequencies. This will be measured via threshold hearing tests. | Within 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in hearing quality with intratympanic NAC injection | The secondary outcome measure of this study will be a comparison of hearing discrimination, subjective tinnitus, otoacoustic emission, speech spatial and quality of hearing between the control and NAC-injected ears. | Within 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Varia Sajeniouk | Contact | 1-416-480-6100 | 85392 | varia.sajeniouk@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Trung N Le | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odette Cancer Centre, Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D003638 | Deafness |
| D006319 | Hearing Loss, Sensorineural |
| D004427 | Ear Diseases |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
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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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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |