von Gruenigen, V., Frasure, H., Fusco, N., DeBernardo, R., Eldermire, E., Eaton, S., & Waggoner, S. (2010). A double-blind, randomized trial of pyridoxine versus placebo for the prevention of pegylated liposomal doxorubicin-related hand-foot syndrome in gynecologic oncology patients. Cancer, 116, 4735–4743.doi: 10.1002/cncr.25262
To compare the efficacy of pyridoxine versus placebo for the prevention of hand-foot syndrome (HFS) in patients with recurrent ovarian, metastatic breast, or endometrial cancer who received pegylated liposomal doxorubicin (PLD) chemotherapy. A secondary objective was to compare quality of life (QOL) between patients who experienced HFS during chemotherapy and those who did not.
Patients were randomly assigned to receive pyridoxine 100 mg BID (group A) or placebo (group B). Patients also received standard HFS education and completed a QOL questionnaire. Incidence of HFS was compared between groups.
Patients were undergoing the active treatment phase of care.
This was a randomized, double-blind, placebo-controlled trial.
Pyridoxine as administered in the current study did not prevent HFS in patients who received PLD. No difference existed in the incidence of HFS between patients who received prophylactic pyridoxine and those who received placebo. In addition, the HFS rash appeared to be tolerable in most patients because it did not disrupt patient-rated QOL in this study.
Findings do not support the effectiveness of pyridoxine in the prevention of HFS. The study was likely underpowered. Additional research is needed on strategies to prevent and manage HFS.