N-acetylcysteine to prevent cisplatin-related hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial comparing NAC versus placebo in patients scheduled for high-dose cisplatin chemotherapy. Hearing is measured with pure-tone audiometry including extended high-frequency testing and distortion product otoacoustic emissions (DPOAE) at baseline, before each cisplatin cycle, and at 1 and 4 months after treatment completion. The primary endpoint is the change in hearing thresholds and pure-tone averages at one month after treatment, with statistical comparisons between groups using appropriate comparative tests. The study aims to determine feasibility and signal of otoprotection from NAC in a clinical chemotherapy setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged between 18 and 70 years
* Patients scheduled to receive high-dose cisplatin-based chemotherapy regimens with a projected cumulative cisplatin dose of \> 200 mg/m2 and each dose \> 50 mg/m2
* Patients may receive concurrent chemotherapy with non-ototoxic agents
* Patients may receive concurrent radiation therapy to the skull base, provided the radiation dose does not exceed the toxic threshold for ototoxicity
* Patients receiving an appropriate antiemetic regimen consisting of Olanzapine or Neurokinin-1 (NK1) receptor antagonists
* Patients receiving medical treatment at Siriraj Hospital.

Exclusion Criteria:

* Patients diagnosed with Nasopharyngeal Carcinoma (CA nasopharynx).
* Patients with a history of head and neck radiation therapy where the radiation dose to the cochlea exceeded 9 Gy or the dose to the eustachian tube exceeded 50 Gy on both sides.
* Patients who have received N-acetylcysteine (NAC) within 2 weeks prior to the start of the study.
* Patients who have received other ototoxic drugs within 2 weeks prior to or during the study, including but not limited to:

Aminoglycoside antibiotics, Vancomycin, Loop diuretics (e.g., Furosemide), High-dose Aspirin, Antimalarial drugs (e.g., Quinine)

\- Patient with a known allergy or hypersensitivity to acetylcysteine.

Where it's running

• Faculty of Medicine Siriraj Hospital, Mahidol University
  Bangkok, Bangkoknoi, Thailand Recruiting

Study contacts

• Principal investigator: Kanthong Thongyai, Master — Siriraj Hospital
• Study coordinator: Naphassakorn Opasatian, Bachelor
• Email: maymnoshikal@gmail.com
• Phone: 66982469575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.