Intratympanic N-Acetylcysteine for Prevention of Cisplatin-induced Ototoxicity.
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- STATUS
- Recruiting
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- End date
- Sep 1, 2023
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- participants needed
- 80
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- sponsor
- Sunnybrook Health Sciences Centre
Summary
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.
Description
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.
Details
| Condition | Ototoxic Hearing Loss |
|---|---|
| Treatment | N-Acetyl Cysteine |
| Clinical Study Identifier | NCT04291209 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Last Modified on | 28 February 2022 |
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