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
- 16
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of advanced colorectal or breast carcinoma
- •Hormone receptor status not specified
- •Receiving single-agent capecitabine chemotherapy
- •Measurable disease for response assessment, determined on an individual patient basis, using conventional clinical and/or radiological methods
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Menopausal status not specified
- •Life expectancy ≥ 12 weeks
- •Hemoglobin ≥ 10 g/dL
- •Platelet count ≥ 100,000 mm^3
- •WBC ≥ 3,000/mm^3
- •ANC ≥ 1,500/mm^3
- •Bilirubin ≤ 1.3 x upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 5 x ULN
- •AST and ALT ≤ 5 x ULN
- •Creatinine ≤ 1.5 x ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •No other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
- •No medical or psychiatric condition which would influence the ability to provide informed consent
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 6 weeks since prior investigational agents
- •Concurrent radiotherapy allowed
- •No other concurrent chemotherapy or immunotherapy
- •No concurrent nonsteroidal anti-inflammatory drugs NSAIDs) for the primary purpose of treating hand-foot syndrome (HFS) or cancer
- •NSAIDs for conditions other than HFS or cancer allowed
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
- Overall toxicity
- 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
研究者
研究点 (16)
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