UnknownPhase 1/2

Intratympanic N-Acetylcysteine for Prevention of Cisplatin-induced Ototoxicity.

Canada80 participantsStarted 2020-02-26

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Advanced stage head and neck cancer * Receiving high dose systemic cisplatin (100mg/m2) with concurrent radiation therapy as part of their curative intent treatment * Willing to provide informed consent * ECOG performance status 0-2 * Histological confirmation of squamous cell carcinoma Exclusion Criteria: * Age less than 18 * Metastatic disease * Tympanic membrane perforation or the presence of tympanostomy tubes as this may impact the retention and absorption of NAC when inserted into the middle ear * Preexisting severe to profound sensorineural hearing loss (unilateral or bilateral) * Pretreatment interaural discrepancy of greater than 10dB at three frequencies * History of Meniere's or fluctuating hearing loss * Previous hypersensitivity to NAC * Patient unable to follow the protocol for any reason

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determination of a safe and tolerable dosage for intratympanic NAC injection

Timeframe: Within 1 day

Improvement in hearing threshold with intratympanic NAC injection

Timeframe: Within 2 months

Trial details

NCT IDNCT04291209

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-01

Contact for this trial

Varia Sajeniouk

1-416-480-6100 varia.sajeniouk@sunnybrook.ca

View on ClinicalTrials.gov More Ototoxic Hearing Loss trials