NCT00486213终止3 期
Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)
National Cancer Centre, Singapore2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2007年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0
研究概览
简要总结
RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer.
PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients with cancer.
详细描述
OBJECTIVES:
Primary
- Compare the incidence of capecitabine-induced palmar-plantar erythrodysesthesia (hand-foot syndrome [HFS]) ≥ grade 2 in patients with cancer treated with pyridoxine hydrochloride vs placebo.
Secondary
- Compare the time to onset of HFS ≥ grade 2 in patients treated with these regimens.
- Compare the quality of life changes in patients treated with these regimens.
- Identify factors predicting toxicity from capecitabine chemotherapy.
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
- Triple (Participant, Care Provider, Investigator)
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 cancer
- •Must be receiving single-agent capecitabine either in the adjuvant/neoadjuvant or palliative setting at a dose of ≥ 1000 mg/m² twice daily on days 1-14 (given in 3-week courses)
- •PATIENT CHARACTERISTICS:
- •Life expectancy > 12 weeks
- •No preexisting neuropathy
- •No known allergy to pyridoxine hydrochloride and its incipients
- •No other dermatologic condition that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior capecitabine
- •Concurrent radiotherapy, steroids, and/or biological therapy (e.g., trastuzumab [Herceptin®] or bevacizumab) allowed provided they do not cause hand-foot syndrome (HFS)
- •No other concurrent drugs (e.g., docetaxel or doxorubicin hydrochloride liposome) that can cause HFS
- •No concurrent drugs (e.g., oxaliplatin or taxanes) that can cause neuropathy
- •No concurrent pyridoxine hydrochloride-containing preparations (e.g., multivitamins or vitamin B complex)
- •No concurrent over-the-counter products that contain urea or lactic acid
- •No concurrent drugs reported to have drug interactions with pyridoxine hydrochloride (e.g., cycloserine; hydralazine; immunosuppressants; isoniazid; levodopa; estrogen or estrogen-containing contraceptives; penicillamine; phenobarbitone; phenytoin; or pyrazinamide)
排除标准
- 未提供
结局指标
主要结局
First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0
时间窗: up to 8 cycles
次要结局
- Time to the onset of HFS ≥ grade 2(days to weeks)
- Quality of life as measured by EuroQOL (EQ-5D) questionnaire(QOL assessment at baseline, at beginning of cycles 2, 4, 6, 8 and at the end of the study.)
研究者
研究点 (2)
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