Recruiting
Phase 1
Phase 2

N-Acetylcysteine

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04291209

Conditions

Ototoxic Hearing Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

N-Acetyl Cysteine

Study Details

Brief 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.

Conditions

Ototoxic Hearing Loss

Study ID

NCT04291209

Start date

Feb 26, 2020

Status verified date

Sep, 2023

Completion date

May 1, 2024

Anticipated

Primary completion date

May 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Experimental arm with Intratympanic NAC injection

One ear will be randomly chosen for the experimental treatment and receive intratympanic NAC injections 60 minutes prior to their scheduled chemotherapy sessions

no intervention: Control arm with No injection

The control ear will not receive any injections

Interventions

N-Acetyl Cysteine

One ear will be randomly chosen for the experimental treatment of intratympanic NAC. The other ear will serve as the control ear which will not receive any injection.

Primary outcome measure

  • Determination of a safe and tolerable dosage for intratympanic NAC injection [ Time Frame: Within 1 day ]
  • Improvement in hearing threshold with intratympanic NAC injection [ Time Frame: Within 2 months ]

Central Contacts and Locations

Central contacts

Varia Sajeniouk

1-416-480-6100varia.sajeniouk@sunnybrook.ca

Locations

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Varia Sajeniouk

1-416-480-6100varia.sajeniouk@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Sep 6, 2023

Last verified

Sep, 2023

Keywords

  • Hearing Loss
  • Deafness
  • Cisplatin-induced Ototoxicity
  • Sensorineural hearing loss
  • Ear diseases
  • Antioxidant
  • N-acetyl cystein

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-09-06.