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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: London Regional Cancer Program, Canada; Toronto Sunnybrook Regional Cancer Centre
• Treatments: Acetylcysteine; Cisplatin; N-monoacetylcystine

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