RPCEC00000195尚未招募3 期
EFFICACY OF VITAMIN E ON THE PREVENTION OF PERIPHERAL NEUROPATHY INDUCED BY CHEMOTHERAPY WITH CISPLATIN AND OXALIPLATIN - CIN-Vit E
Drug Research and Development Center CIDEM)0 个研究点目标入组 200 人开始时间: 2015年5月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Prevention
入排标准
- 年龄范围
- 19 years 至 70 years（—）
- 性别
- All
入选标准
- •1. Patients with lung, breast, gastrointestinal or head and neck neoplasia, tributary of treatment with cisplatin or oxaliplatin.
- •2. Patients without clinical or electrophysiological diagnosis of peripheral neuropathy at the time of entry.
- •3. Subjects of both gender, ranged between 19 and 70 years (both inclusive).
- •4. Patient’s written, informed consent.
排除标准
- •1. Antecedents or clinical evidence of the following pathologies: Some previous type of peripheral neuropathy, family story of any type of inherited-familiar neuropathy.
- •2. Patients who have received prior chemotherapy.
- •3. Patients who have received drugs that can produce peripheral nerve damage.
- •4. Severe acute diseases at the time of entry.
- •5. Diabetes Mellitus
- •6. Patients receiving treatment with Amifostine, acetyl L carnitine, Glutanine, erythropoietin and infusions of Ca and Mg.
- •7. Hypersensitivity to the active substance (Vitamin E) or some of the inactive substances that are present in the formulation.
- •8. Concurrent participation in another clinical trial.
研究者
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