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Clinical Trials/ACTRN12606000161527
ACTRN12606000161527
Withdrawn
Not Applicable

Randomised double-blind placebo controlled trial of pyridoxine for prevention of capecitabine induced hand-foot syndrome

Dr Chris Karapetis0 sites288 target enrollmentMay 8, 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Capecitabine induced hand-foot syndrome (HFS)
Sponsor
Dr Chris Karapetis
Enrollment
288
Status
Withdrawn
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 8, 2006
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Dr Chris Karapetis

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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