Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- - Extended high frequency audiogram - DPOAE
研究概览
简要总结
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).
详细描述
This study is designed as a randomized, double-blind, controlled] trial to investigate the protective effects of N-acetylcysteine (NAC) against cisplatin-induced hearing loss.
Patients scheduled to receive cisplatin chemotherapy will be enrolled. The primary objective is to compare the changes in hearing thresholds between the intervention group (receiving NAC) and the control group. Hearing function will be comprehensively evaluated using:
Pure-tone Audiometry (including Extended High-Frequency Audiometry).
Distortion Product Otoacoustic Emissions (DPOAE) to assess outer hair cell function.
Evaluations will be conducted at baseline (before chemotherapy) and before every cycle of cisplatin administration and 1 month and 4 month after completion . Statistical analysis will include descriptive statistics and comparative tests (such as Unpaired T-tests or Generalized Estimating Equations) to determine the significance of hearing threshold shifts. The study aims to provide evidence on the feasibility and effectiveness of NAC in preserving auditory function in cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
N acetylcysteine
NAC at a dosage of 150 mg/kg in 5%DW 200 mL intravenous 4-6 hour after completion of cisplatin
干预措施: Acetyl cysteine (Drug)
Control Group
Normal saline 200 mL intravenous 4-6 hour after completion of cisplatin
干预措施: Normal Saline (Drug)
结局指标
主要结局
- Extended high frequency audiogram - DPOAE
时间窗: 1 month after completion of cisplatin therapy
Compare hearing levels between the N-Acetylcysteine group and the placebo group in patients receiving cisplatin, at one month after the completion of treatment by audiometry in term of each frequency and Pure tone average of 500,1000,2000 and 500,1000,2000,4000 and DPOAE
次要结局
- - Extended high frequency audiogram - DPOAE(Prior to each cisplatin cycle administration and 4 months after completion of treatment)
- The subsequent otologic symptoms following cisplatin therapy(1 month and 4 month after treatment)
研究者
Naphassakorn Opasatian
Protective Effect of Acetylcysteine against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial
Siriraj Hospital