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New treatment option for Cisplatin-induced Ototoxicity
Official title Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07364747
What this study is testing
What is Acetyl cysteine?
Acetyl cysteine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cisplatin-induced ototoxicity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok, Bangkoknoi, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok, Bangkoknoi, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.