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.
Who is this study for? Patients with Ototoxic Hearing Loss
What treatments are being studied? N-Acetyl Cysteine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:
• 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
Locations
Other Locations
Canada
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Recruiting
Toronto
Contact Information
Primary
Varia Sajeniouk
varia.sajeniouk@sunnybrook.ca
1-416-480-6100
Time Frame
Start Date: February 26, 2020
Estimated Completion Date: September 1, 2023
Participants
Target number of participants: 80
Treatments
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
Authors
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre
Collaborators: Toronto Sunnybrook Regional Cancer Centre, London Regional Cancer Program, Canada