A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Incidence of Hand-Foot Syndrome (HFS)
研究概览
简要总结
Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.
详细描述
Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of Hand-Foot Syndrome (HFS) that occurred in both study arms.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult patient starting capecitabine-containing chemotherapy
- •Has never had capecitabine before
- •Performance status 0-2 using the ECOG classification
- •Life expectancy more than 6 months
- •Agreed to stop any vitamin supplements, apart from vitamin D.
- •Liver function studies including AST/ALT within 3x upper limit of normal
- •Signed informed consent must be obtained from participating individuals
排除标准
- 未提供
研究组 & 干预措施
vitamin B6
patient receiving xeloda and vitamin B6
干预措施: Vitamin B 6 (Drug)
2 placebo
patient receiving xeloda and placebo
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of Hand-Foot Syndrome (HFS)
时间窗: 1 year
Incidence of HFS based on CTCTAE adverse event table
次要结局
- Grade of Hand-Foot Syndrome (HFS)(1 year)
研究者
Pamela Gonzalez Sr Director Clinical Research Office
Dir Clinical Research Office
Cook County Health