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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2021
  • participants needed
    80
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 24 January 2021

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.

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.

Details
Condition Ototoxic Hearing Loss
Treatment N-Acetyl Cysteine
Clinical Study IdentifierNCT04291209
SponsorSunnybrook Health Sciences Centre
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Ototoxic Hearing Loss?
Do you have any of these conditions: Do you have Ototoxic Hearing Loss??
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
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