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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04291209
Recruitment Status : Recruiting
First Posted : March 2, 2020
Last Update Posted : October 25, 2022
Sponsor:
Collaborators:
Toronto Sunnybrook Regional Cancer Centre
London Regional Cancer Program, Canada
Information provided by (Responsible Party):
Dr. Trung Le, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE February 26, 2020
First Posted Date  ICMJE March 2, 2020
Last Update Posted Date October 25, 2022
Actual Study Start Date  ICMJE February 26, 2020
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
  • Determination of a safe and tolerable dosage for intratympanic NAC injection [ Time Frame: Within 1 day ]
    The primary end-point of the phase 1 part of this study is the safety and tolerability of intratympanic NAC injections, by determining the causality of adverse events and serious adverse events and grading according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v.5.0
  • Improvement in hearing threshold with intratympanic NAC injection [ Time Frame: Within 2 months ]
    The primary outcome measure of this study will be a comparison of hearing loss between the control and NAC-injected ears. More specifically, each ear will be scored as having hearing loss if there is a greater than 10dB hearing loss in three contiguous frequencies. This will be measured via threshold hearing tests.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2020)		 Improvement in hearing quality with intratympanic NAC injection [ Time Frame: Within 2 months ]
The secondary outcome measure of this study will be a comparison of hearing discrimination, subjective tinnitus, otoacoustic emission, speech spatial and quality of hearing between the control and NAC-injected ears.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intratympanic N-Acetylcysteine for Prevention of Cisplatin-induced Ototoxicity.
Official Title  ICMJE Intratympanic N-Acetylcysteine (NAC) Injections for Prevention of Cisplatin-induced Ototoxicity in Head and Neck Cancer Patients: A Multi-centre Phase II Randomized Controlled Trial.
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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Ototoxic Hearing Loss
Intervention  ICMJE Drug: 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.
Other Name: NAC
Study Arms  ICMJE
  • 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
    Intervention: Drug: N-Acetyl Cysteine
  • No Intervention: Control arm with No injection
    The control ear will not receive any injections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2020)		 80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2023
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Varia Sajeniouk 1-416-480-6100 ext 85392 varia.sajeniouk@sunnybrook.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04291209
Other Study ID Numbers  ICMJE 1819
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Dr. Trung Le, Sunnybrook Health Sciences Centre
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Toronto Sunnybrook Regional Cancer Centre
  • London Regional Cancer Program, Canada
Investigators  ICMJE
Principal Investigator: Trung N Le Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP