EUCTR2007-002787-95-NL进行中（未招募）1 期
A randomized double-blind study of N-Acetylcysteine vs. placebo to Prevent Neurotoxicity induced by Platinum containing chemotherapy in patients treated for (Non)Small Cell Lung Cancer and Malignant Mesothelioma. - NAC-PNP-study
Department of Pulmonology, Rijnstate Hospital0 个研究点开始时间: 2007年9月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-diagnose is histologically or cytologically proven (NSCLC,SCLC), malignant mesothelioma (histologically)
- •-at least 4 cycles of cisplatin are planned
- •-adequate renal function (creatinine clearance as calculated by Cockroft-Gault method > 60 ml/min)
- •- Karnofski performance score > 60 %
- •-written informed consent
- •-patient must be able to comply with study measurements i.e. hospital visits for EMG and QoL assessments
- •-age = 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-patients with pre-existing neuropathy
- •-patients not willing to stop earlier prescribed NAC
- •-patients not willing to stop vitamins E and A above daily advisory dosage
- •-uncontrolled metastasis in the central or peripheral nervous system
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