Status:
UNKNOWN
Intratympanic N-Acetylcysteine for Prevention of Cisplatin-induced Ototoxicity.
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Toronto Sunnybrook Regional Cancer Centre
London Regional Cancer Program, Canada
Conditions:
Ototoxic Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 rand...
Detailed 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 heari...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04291209
Start Date
February 26 2020
End Date
May 1 2024
Last Update
September 6 2023
Active Locations (1)
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1
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5