N-Acetylcysteine Role on Urinary KIM-1 and Serum Creatinine Level in Cancer Patient With Cisplatin Based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Kidney injury molecule-1
研究概览
简要总结
The goal of this clinical trial is to learn if N-Acetylcysteine drug works to protect kidney function in adults patient with cancer. Kidney function will be measured by laboratory parameter using urine sample (KIM-1 urine) and blood sample (serum creatinine). The main questions it aims to answer are:
- Does N-Acetylcysteine lower the level of KIM-1 (Kidney Injury Molecule) in patients urine indicating kidney function protection?
- Does N-Acetylcysteine lower the level of creatinine in patients blood indicating kidney function protection?
Participants will:
- Had their blood and urine sample taken before taking the drugs (N-Acetylcysteine or placebo)
- Underwent cisplatin based chemotherapy
- Taken placebo or N-Acetylcysteine for seven days (1 day before chemotherapy, on the chemotherapy day, and 5 days after chemotherapy)
- Had their blood and urine sample taken twice after taking the drugs (1 week and 3 weeks after chemotherapy)
- Had their symptoms monitor during and after taking the drugs. Every possible side effect, hospitalization, or death will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with cancer/ malignancy proven by histopathological examination
- •Patient with GFR ≥60 ml/mins/1,73 m²
- •Patient with normal complete blood count and liver function test result
- •Patient with good performance status (Karnofsky score ≥80)
- •Patients with cisplatin based chemotherapy
排除标准
- •Patient that can not tolerate N-Acetylcysteine usage
- •Patient with history of hypersensitivity to N-Acetylcysteine
- •Patient that given other potentially nephrotoxic drug, such as furosemide, non-steroidal anti-infammatory drugs, aminoglycosides, amphotericin B, cephalosporine
- •Patient that given other chemotherapy drug, such as permetrexed, ifosfamide, gemcitabin, bevacizumab, cetuxsimab
- •Patient with history of malignant or uncontrolled hypertension
- •patient with congestive heart failure, kidney structure abnormality, and acute infection
- •Pregnant or lactating women
- •Patient refusing to participate in the research
研究组 & 干预措施
Placebo
Patient receiving placebo and cisplatin chemotherapy
干预措施: Placebo (Drug)
N-Acetylcysteine
Patient receiving NAC + cisplatin based chemotherapy
干预措施: N-acetylcysteine (NAC) (Drug)
结局指标
主要结局
Kidney injury molecule-1
时间窗: 1 week and 3 weeks after intervention
Detected from participants urine sample indicating kidney function, will be measured at baseline, and after the intervention
Creatinine
时间窗: 1 week and 3 weeks after intervention
Creatinine will be measured from participants blood serum sample at baseline, and after intervention
次要结局
未报告次要终点
研究者
Oryza Gryagus Prabu, MD
Medical Staff, Internist
Fakultas Kedokteran Universitas Indonesia