Clinical trial · Interventional
Intratympanic N-Acetylcysteine for Prevention of Cisplatin-induced Ototoxicity.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ototoxic Hearing Loss | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N-Acetyl Cysteine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Experimental arm with Intratympanic NAC injection
- description
- One ear will be randomly chosen for the experimental treatment and receive intratympanic NAC injections 60 minutes prior to their scheduled chemotherapy sessions
- interventionNames
- Drug: N-Acetyl Cysteine
- type
- NO_INTERVENTION
- label
- Control arm with No injection
- description
- The control ear will not receive any injections
Primary outcomes (2)
- measure
- Determination of a safe and tolerable dosage for intratympanic NAC injection
- timeFrame
- Within 1 day
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available