NCT00559858Unknown3 期
A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 270
- 试验地点
- 32
- 主要终点
- Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
研究概览
简要总结
RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome.
PURPOSE: This phase III randomized trial is studying pyridoxine to see how well it works compared to a placebo in preventing hand-foot syndrome in patients who are receiving capecitabine for advanced colorectal cancer or breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether pyridoxine can reduce the incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.
Secondary
- Determine the incidence of hand-foot syndrome (HFS).
- Determine the overall toxicity.
- Determine the quality of life.
- Determine the response to chemotherapy.
- Determine the progression-free survival.
- Determine the level of biomarkers which might predict the occurrence of HFS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
次要结局
- Measurement of biomarkers that might predict the occurrence of HFS
- Response to chemotherapy
- Progression-free survival
- Incidence of hand-foot syndrome (HFS)
- Quality of life
- Overall toxicity
研究者
研究点 (32)
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