Kang, Y.K., Lee, S.S., Yoon, D.H., Lee, S.Y., Chun, Y.J., Kim, M.S., . . . Kim, T.W. (2010). Pyridoxine is not effective to prevent hand-foot syndrome associated with capecitabine therapy: Results of a randomized, double-blind, placebo-controlled study. Journal of Clinical Oncology, 28, 3824–3829.doi: 10.1200/JCO.2010.29.1807
To determine whether concurrent pyridoxine therapy can prevent the development of hand-foot syndrome (HFS) in patients being treated with capecitabine.
Chemotherapy-naïve patients with gastrointestinal (GI) tract cancers who were scheduled for capecitabine-containing chemotherapy were randomly assigned to concurrent oral pyridoxine (200 mg per day) or placebo. Patients were stratified by chemotherapy regimen and monitored until development of HFS with a National Cancer Institute (NCI) common toxicity criteria of grade 2 or worse, or capecitabine-containing chemotherapy ended. Patients in the placebo group who developed grade 2 or worse HFS were randomly assigned again to received pyridoxine or placebo in the next chemotherapy cycle to determine whether pyridoxine could improve HFS.
The site and setting types were not specified.
Patients were undergoing the active treatment phase of care.
This was a randomized, double-blinded, placebo-controlled trial.
Pyridoxine is not effective in the prevention of capecitabine-associated HFS.
This trial did not include pathophysiologic analysis, which could have provided additional information on the pathogenesis of capecitabine-induced HFS.
Pyridoxine prophylaxis was shown to have no effect on reducing the development or severity of HFS.