Wolf, S.L., Qin, R., Menon, S.P., Rowland, K.M., Jr, Thomas, S., Delaune, R., . . . Loprinzi, C.L. (2010). Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North Central Cancer Treatment Group Study N05C5. Journal of Clinical Oncology, 28, 5182–5187.
To determine the effectiveness of a urea/lactic acid–based topical keratolytic agent (ULABTKA) for the prevention of capecitabine-induced hand-foot syndrome (HFS).
Eligible patients received their first dose of capecitabine at 2,000 or 2,500 mg/m2 per day for 14 days, every 21 days. Patients then were randomized to the ULABTKA arm or placebo cream. Creams were applied to the hands and feet BID for 21 days over four consecutive cycles. Patients kept a daily diary. Toxicity data were collected at baseline and the end of each 21 day cycle. The primary end point was incidence of moderate or severe HFS in the first cycle, based on patient report. Secondary end points included the incidence of moderate or severe HFS by physician grading, times to grade, and physician determination.
Patients were undergoing the active treatment phase of care.
This was a randomized, double-blind, phase 3 clinical trial.
The use of urea/lactic acid for the prevention of HFS in patients receiving capecitabine therapy cannot be supported on the basis of this trial.
The primary end point only concerned the first 21-day cycle, rather than looking over the planned four cycles. This raises the question over whether more power could have existed to detect smaller differences. More patients received the lower dose of capecitabine.
Nurses should educate patients to limit or not use urea/lactic acid cream if starting on capecitabine.