TerminatedNot Applicable

Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy

Stopped: incomplete enrollment

United States6 participantsStarted 2006-03-21

Plain-language summary

Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.

Who can participate

SexALL

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Inclusion Criteria: * Any adult patient starting capecitabine-containing chemotherapy * Has never had capecitabine before * Performance status 0-2 using the ECOG classification * Life expectancy more than 6 months * Agreed to stop any vitamin supplements, apart from vitamin D. * Liver function studies including AST/ALT within 3x upper limit of normal * Signed informed consent must be obtained from participating individuals

What they're measuring

Incidence of Hand-Foot Syndrome (HFS)

Timeframe: 1 year

Trial details

NCT IDNCT00767689

SponsorCook County Health

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2009-03-18

View on ClinicalTrials.gov More Hand and Foot Syndrome trials