Role of N-Acetylcysteine for Prevention of Cisplatin-induced Nephrotoxicity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Estimation of Acute kidney injury to participant
研究概览
简要总结
Cisplatin is one of the first-line drugs used against many malignancies, such as lung cancer, head and neck cancer, esophageal cancer, gastric cancer, colorectal cancer, urothelial cancer, bladder cancer and testicular cancer. The usage of Cisplatin is limited by its severe nephrotoxicity, which particularly affects the proximal tubule epithelial cells (PTEC).Several studies suggest role of NAC in ameliorating Cisplatin induced nephrotoxicity, although definitive data is lacking. N-Acetylcysteine (NAC) is a thiol-containing antioxidant, which not only acts as a precursor of glutathione but also as a direct antioxidant .There are multiple postulated mechanisms for NAC's nephroprotection. NAC is a low-cost, easily available drug with a very good safety profile and therefore can be added as a support medication during treatment with cisplatin. The investigators plan to administer 1200 mg oral NAC 12 hours before chemotherapy and then daily at night for the subsequent 6 days, with an objective to ascertain its nephroprotective role in population receiving Cisplatin/-based chemotherapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female outpatients with non-hematological malignancies (Breast, ovary and head and neck squamous cell carcinomas)
- •Having Eastern Cooperative Oncology Group(ECOG) Performance Status ≤2 who had never received platinum based Chemotherapy in past and were now scheduled to receive high-dose cisplatin chemotherapy.
- •Patients were required to have estimated glomerular filtration rate (GFR)(according to Cockcroft-Gault formula) ≥ 60 ml/min at start of chemotherapy regimen with normal Blood Counts, Liver, and kidney function tests
排除标准
- •Patients who had poor performance status i.e., ECOG Performance Status 3 or 4
- •Who declined to participate at any time during the course of the study
- •Patients having hepatic failure (Liver Function tests >3 times of upper limit normal)
- •Patients who did not tolerate the use of NAC or were administered the drug <70% of the time
- •Patient who were receiving concurrent nephrotoxic drugs, or having history of Hypersensitivity to N-Acetyl cysteine.
研究组 & 干预措施
Cisplatin group
This group of Patients will receive Cisplatin-base chemotherapy as per the designated schedule, alongside standard hydration protocol
干预措施: Chemotherapy (Drug)
N-acetylcysteine group
Patients in the NAC arm to be given N-acetylcysteine 1200 mg/day starting 12 hrs before till 6 days after Cisplatin-based chemotherapy administration. Hydration according to standard hydration protocol will be given.
干预措施: N-Acetylcysteine (Drug)
N-acetylcysteine group
Patients in the NAC arm to be given N-acetylcysteine 1200 mg/day starting 12 hrs before till 6 days after Cisplatin-based chemotherapy administration. Hydration according to standard hydration protocol will be given.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Estimation of Acute kidney injury to participant
时间窗: 18 weeks
Acute kidney injury will be assessed by RIFLE criteria that will be calculated for patients
Blood urea nitrogen of participant
时间窗: 18 weeks
Blood samples collected and measured in laboratory with the unit mg/dl
Serum creatinine of participant
时间窗: 18 weeks
Blood samples collected and measured in laboratory with the unit mg/dL
Creatinine clearance of participant
时间窗: 18 weeks
It will be calculated using Cockroft-Gault formula , unit ml/min
次要结局
未报告次要终点