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

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

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.

Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of Hand-Foot Syndrome (HFS) that occurred in both study arms.

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