A Phase 1/2 interventional study of N-Acetyl Cysteine in Ototoxic Hearing Loss, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Sunnybrook Health Sciences Centre · Phase 1/2, Interventional, and Prevention
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.
1,110 studies on the registry are indexed under Hearing Loss; 233 are open to participants now.
This study's planned enrollment of 80 is above the median of 40 across 778 interventional studies indexed under Hearing Loss.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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One ear will be randomly chosen for the experimental treatment and receive intratympanic NAC injections 60 minutes prior to their scheduled chemotherapy sessions
Drug: N-Acetyl Cysteine
The control ear will not receive any injections
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.
Also known as: NAC
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
Time frame: 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.
Time frame: Within 2 months
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.
Time frame: Within 2 months
Plan to share: No
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This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetylcysteine
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