Evaluation of Acetyl-L-Carnitine (ST 200) to reduce intensity of taxanes- or platinum-induced sensory neuropathy

Sigma-Tau (Italy)0 个研究点目标入组 172 人开始时间: 2005年8月2日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•Current inclusion criteria as of 05/11/2007:
•Patients (male and female aged 18 or more years and Karnofsky greater than 60) previously treated with taxanes- or platinum-based chemotherapy and presenting sensory neuropathy, will be randomised to receive placebo or Acetyl-L-Carnitine.
•Previous inclusion criteria:
•Patients (male and female age between 18 and 70 years and Karnofsky >60) previously treated with taxanes- or platinum-based chemotherapy and presenting sensory neuropathy, will be randomised to receive placebo or Acetyl-L-Carnitine.

•1. Pre-existing neuropathies of different origin than those considered in this trial
•2. Diabetes mellitus, insulin-dependent
•3. Symptomatic brain metastases
•4. Leptomeningeal involvement
•5. Significant infective ilness or active inflamed focus
•6. Concomitant therapy with other neuroprotective agents
•7. Any previous use of neuro-protectant drugs if performed from the last chemoteraphy administration, onwards
•8. Any neurotoxic chemotherapy since one month prior to baseline
•9. Predictable lack of patient's co-operation
•10. Pregnancy, nursing, or women of childbearing potential not using an effective method of birth control
•11. Previous treatment with platinum for those patients who enter the study due to taxanes-induced sensory neuropathy
•12. Previous treatment with taxanes for those patients who enter the study due to platinum-induced sensory neuropathy

发起方

Sigma-Tau (Italy)