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 : March 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ototoxic Hearing Loss||Drug: N-Acetyl Cysteine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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.|
|Actual Study Start Date :||February 26, 2020|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
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
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
No Intervention: Control arm with No injection
The control ear will not receive any injections
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291209
|Contact: Varia Sajeniouk||1-416-480-6100 ext firstname.lastname@example.org|
|Odette Cancer Centre, Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Varia Sajeniouk 1-416-480-6100 ext 85392 email@example.com|
|Principal Investigator:||Trung N Le||Sunnybrook Health Sciences Centre|