Randomized, Placebo Controlled Study of Vitamin E for Oxaliplatin-induced Neuropathy Prophylaxis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Incidence and grade of Peripheral neuropathy by common terminology criteria for adverse events v 3.0(CTCAE)and specific Ox PN gradation scales.
研究概览
简要总结
Introduction: Oxaliplatin (Ox) is a frequently used platinum-based medication that is a part of many chemotherapy regimens for the treatment of several gastrointestinal malignancies. One of the most important limitations to its use is the induction of both acute and chronic peripheral neuropathy (PN). Previous studies have shown that vitamin E can reduce the incidence of cisplatin-induced PN by 50%. In this study, the investigators aimed to determine if vitamin E could also prevent Ox-induced acute PN
详细描述
This was a prospective, phase II, randomized pilot study. Patients were randomized 5 days before the start of Ox to receive either vitamin E at 400 mg daily or placebo, until after the end of the Ox-based chemotherapy regimen. The investigators evaluated PN intensity using the CTCAE version 3 and specific Ox PN gradation scales. The investigators included patients with colorectal and gastric cancers scheduled to receive Ox-based chemotherapy. Both groups received calcium and magnesium supplements before and after oxaliplatin infusions.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •ECOG Performance status 0 or 1
- •Older than 18 years
- •New diagnose with colorectal or gastric cancer
- •Scheduled to receive oxaliplatin-based regimens
排除标准
- •Excluded patients with a previous history of PN or with symptomatic PN at entry into the study
- •Excluded patients who received other chemotherapy regimens (except isolated 5-fluorouracil)
- •Patients currently receiving gabapentin, carbamazepine, amitriptyline, amifostine or multivitamins
研究组 & 干预措施
Control Group
Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
干预措施: Placebo (Drug)
Vitamin e
Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
干预措施: Vitamin E (Drug)
结局指标
主要结局
Incidence and grade of Peripheral neuropathy by common terminology criteria for adverse events v 3.0(CTCAE)and specific Ox PN gradation scales.
时间窗: Within the first 45 days (plus or minus 7 days) of treatment ( 3 x oxaliplatin infusions)
次要结局
未报告次要终点
研究者
Felipe Melo Cruz
Director
Faculdade de Medicina do ABC