Using N-Acetylcysteine to prevent hearing loss from chemotherapy
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.
This study is testing if N-Acetylcysteine injections can help prevent hearing loss in patients with advanced head and neck cancer who are receiving high-dose chemotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04291209 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intratympanic N-Acetylcysteine (NAC) injections in preventing hearing loss in patients with advanced head and neck cancer undergoing high-dose cisplatin chemotherapy. It employs a randomized controlled design where one ear receives the NAC treatment while the other serves as a control. Participants will undergo hearing tests before treatment and again two months after completing their cancer therapy to assess the impact of the intervention on hearing preservation.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced stage head and neck cancer who are scheduled to receive high-dose cisplatin as part of their treatment.
Not a fit: Patients with preexisting severe hearing loss or those with conditions affecting ear health may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of hearing loss in patients receiving cisplatin chemotherapy.
How similar studies have performed: Previous studies have shown promise with NAC in reducing ototoxicity, making this approach a potentially valuable addition to current treatment protocols.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- Odette Cancer Centre, Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Trung N Le — Sunnybrook Health Sciences Centre
- Study coordinator: Varia Sajeniouk
- Email: varia.sajeniouk@sunnybrook.ca
- Phone: 1-416-480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.