The Effect of Pyridoxine for Prevention of Hand-Foot Syndrome in Colorectal Cancer Patients with Adjuvant Chemotherapy Using Capecitabine: A Randomized Study.

UNLABELLED: BACKGROUND/Aims: To determine the effect of the pyridoxine for prevention of hand-foot syndrome in colorectal cancer patients with adjuvant chemotherapy using capecitabine. METHODOLOGY: Colorectal cancer patients scheduled for capecitabine chemotherapy as adjuvant setting were randomly assigned to with or without concurrent oral pyridoxine (60 mg/d) groups. Patients were monitored whether being a development of National Cancer Institute Common Toxicity Criteria grade 2 or worse HFS until chemotherapy ended. RESULTS: Sixty patients were enrolled in this study. Relative dose intensity was 89.5% in total. The median number of chemotherapy cycles to grade 2 or worse HFS was four in both groups. Grade 2 or worse HES developed in 18 (60.0%) of 30 control patients and in 18 (60.0%) of 30 pyridoxine patients. The cumulative dose of capecitabine to grade 2 or worse HFS was not different between the two groups. CONCLUSIONS: Pyridoxine is not effective in prevention of capecitabine-associated HFS.