Clinical Trial: A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title:

Brief 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.

Detailed Summary:
Sponsor: John H. Stroger Hospital

Current Primary Outcome: To determine the incidence of vitamine B6 in patient receiving vitamin b6 [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The severity of hand and foot syndrome in patients receiving capecitabine [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: John H. Stroger Hospital

Dates:
Date Received: October 6, 2008
Date Started: May 2008
Date Completion: May 2010
Last Updated: August 3, 2009
Last Verified: August 2009