Overview
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.
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 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.
Eligibility
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