JPRN-UMIN000002932已完成2 期
Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer - Prophylactic pyridoxine for hand-foot syndrome in patients treated with capacitabine for locally advanced or metastatic breast cancer
Tokai Breast Cancer Clinical Research Group (TBCRG)0 个研究点目标入组 135 人开始时间: 2010年1月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
研究概览
简要总结
A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no pyridoxine groups, respectively.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1.History of serious drug hypersensitivity or a history of drug allergy by fluoropyrimidine. History of adverse drug reaction caused by fluoropyrimidines with suspected dihydropyrimidine dehydrogenase deficiency 2.Capecitabine used prior chemotherapy 3.History of drug hypersensitivity not suitable for this study 4.Uncontrolled serious complications 5.Multiple primary cancer within 5 years 6.Pregnant women or possibly pregnant women 7.Other conditions not suitable for this study
研究者
相似试验
已完成
不适用
The effect of pyridoxine for prevention of hand-foot syndrome in colon cancer patients with adjuvant chemotherapy using capecitabine: a randomized studycolon cancerJPRN-UMIN000007314Yokohama City University70
已完成
3 期
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for CancerDrug/Agent Toxicity by Tissue/OrganEndometrial CancerFallopian Tube CancerPeritoneal Cavity CancerBreast CancerOvarian CancerNCT00245050Case Comprehensive Cancer Center34
终止
3 期
Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With CancerDermatologic ComplicationsPalmar-plantar ErythrodysesthesiaUnspecified Adult Solid Tumor, Protocol SpecificNCT00486213National Cancer Centre, Singapore210
Unknown
3 期
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast CancerPalmar-plantar ErythrodysesthesiaColorectal CancerBreast CancerNCT00559858Cambridge University Hospitals NHS Foundation Trust270
已完成
3 期
Study of Pyridoxine for Hand-Foot SyndromeHand-foot SyndromeNCT00446147Asan Medical Center389