Intratympanic N-Acetylcysteine for Prevention of Cisplatin-induced Ototoxicity.
Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Feb 27, 2020
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a medication called N-Acetylcysteine (NAC) to help prevent hearing loss caused by a chemotherapy drug called cisplatin, which is often used to treat advanced head and neck cancer. The trial aims to find the best dose of NAC when injected into the ear and see how effective it is at protecting hearing in patients undergoing treatment. The researchers hope that by using this antioxidant, they can reduce the risk of hearing problems associated with cisplatin.
To be eligible for this trial, participants must be adults aged 18 and older with advanced stage head and neck cancer who are receiving high doses of cisplatin along with radiation therapy. They should also be in good overall health, as indicated by their performance status, and have a confirmed diagnosis of a specific type of cancer called squamous cell carcinoma. Participants will have regular visits where they will receive the NAC injections and undergo monitoring to assess their hearing. It’s important to know that individuals with certain conditions, like severe hearing loss or a history of ear problems, will not be able to participate. This study is currently open for recruitment, meaning they are looking for eligible patients to join.
Gender
ALL
Eligibility criteria
- 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
About Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre is a leading academic health science organization located in Toronto, Canada, renowned for its commitment to advancing patient care through innovative research and education. As a prominent clinical trial sponsor, Sunnybrook integrates cutting-edge medical research with clinical practice, focusing on a wide range of health disciplines, including cancer care, trauma, and cardiovascular health. The center collaborates with various stakeholders, including academic institutions, healthcare providers, and industry partners, to facilitate the development of novel therapies and improve health outcomes. With a robust infrastructure and a dedicated team of researchers and clinicians, Sunnybrook plays a pivotal role in translating scientific advancements into tangible benefits for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toronto, Ontario, Canada
Patients applied
Trial Officials
Trung N Le
Principal Investigator
Sunnybrook Health Sciences Centre
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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