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

Ototoxic Hearing Loss

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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

Study Location

Odette Cancer Centre, Sunnybrook Health Sciences Centre
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Varia Sajeniouk

[email protected]
1-416-480-6100
Study Sponsored By
Sunnybrook Health Sciences Centre
Participants Required
More Information
Study ID: NCT04291209