A randomised placebo-controlled study evaluating the role of pyridoxine in controlling capecitabine-induced hand-foot syndrome

Cambridge University Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 270 人开始时间: 2006年2月6日最近更新: 2020年4月6日

适应症

试验速览

•1. Patients with advanced colorectal or breast carcinoma receiving single agent capecitabine chemotherapy
•2. No other concomitant chemotherapy or immunotherapy
•3. Life expectancy more than 12 weeks
•4. Performance status zero, one or two (Eastern Cooperative Oncology Group [ECOG] performance scale)
•5. Aged over 18 years
•6. Laboratory parameters:
•a. Haemoglobin B more than 10 g/dl
•b. Platelets more than 100,000 mm^3
•c. White Cell Count (WCC) more than 3.0 x 10^9/l
•d. Absolute Neutrophil Count (ANC) more than 1.5 x 10^9/l
•e. Bilirubin less than 1.3 times Upper Limit of Normal (ULN)
•f. Alkaline phosphatase less than five times ULN
•g. Transaminases less than five times ULN
•h. Creatinine less than 1.5 times ULN
•7. Written informed consent provided by the patient
•8. Radiotherapy during the study period is allowed
•9. Women of child-bearing potential must have a negative pregnancy test prior to study entry and be using adequate contraception, which must be continued for three months after the study

•1. Any concomintant chemotherapy or immunotherapy
•2. Any previous investigational agent within the last six weeks
•3. Any other serious or uncontrolled illness, which in the opinion of the investigator, makes it undesirable for the patient to enter the trial
•4. Any medical or psychiatric condition which would influence the ability to provide informed consent

发起方