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Taking peoplePhase 2

Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial

Key facts

Who runs it
Siriraj Hospital
Where
Thailand1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
40 people, planned
Started
23 Dec 2024
Expected to end
31 Mar 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Acetyl cysteine
  • Normal Saline
Record updated
23 January 2026

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • Patient with a known allergy or hypersensitivity to acetylcysteine
  • Patients diagnosed with Nasopharyngeal Carcinoma (CA nasopharynx)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The purpose of this study is to evaluate the efficacy of N-acetylcysteine (NAC) in preventing cisplatin-induced ototoxicity in patients receiving cisplatin-based chemotherapy. Cisplatin is a highly effective chemotherapeutic agent but often leads to permanent hearing loss (ototoxicity) as a significant side effect. This study investigates whether the administration of NAC as an otoprotective agent can reduce or prevent the decline in hearing sensitivity, particularly at extended high frequencies, as measured by audiometry and distortion product otoacoustic emissions (DPOAE).

The 2 groups in the trial

  • N acetylcysteineTreatment being tested

    NAC at a dosage of 150 mg/kg in 5%DW 200 mL intravenous 4-6 hour after completion of cisplatin

    Treatment: Acetyl cysteine

  • Control GroupPlacebo, for comparison

    Normal saline 200 mL intravenous 4-6 hour after completion of cisplatin

    Treatment: Normal Saline

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT07364747, who can take part
Record updated
23 January 2026