Randomised double-blind placebo controlled trial of pyridoxine for prevention of capecitabine induced hand-foot syndrome
Withdrawn
- Conditions
- Capecitabine induced hand-foot syndrome (HFS)Blood - Other blood disorders
- Registration Number
- ACTRN12606000161527
- Lead Sponsor
- Dr Chris Karapetis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 288
Inclusion Criteria
Commencement of capecitabine at a dose of 800mg/m2 BD every 2 out of 3 weeks either as single agent or combination therapySigned informed consent. Life expectancy greater than 12 weeksConcommitant radiotherapy or steroids permitted
Exclusion Criteria
Prior capecitabine chemotherapy over the past 30 daysInability to provide informed consentConcommitant administration of drugs that cause HFS eg docetaxel, liposomal doxorubicinConsumption of pyridoxine-containing preparationsAnticipated inability to follow up patient for side effects of chemotherapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Grade 2 or greater Hand Foot Syndrome (HFS)[ Assessed clinically every three weeks, and via phone contact weekly];Severity is graded according to Commom Toxicity Criteria for Adverese Events (CTCAE) Version 3 [ Assessed clinically every three weeks, and via phone contact weekly]
- Secondary Outcome Measures
Name Time Method Time to onset of grade 2 or higher HFS will be evaluated in days.[ The duration of treatment is 24 weeks.<br>Assessment for the primary end-point will occur at clinic visitsand via weekly phone calls from the research nurse.]