ACTRN12606000161527WithdrawnNot Applicable
Randomised double-blind placebo controlled trial of pyridoxine for prevention of capecitabine induced hand-foot syndrome
Dr Chris Karapetis0 sites288 target enrollmentStarted: May 8, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 288
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to ot stated (—)
- Sex
- All
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.
Investigators
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