Study Status: No longer available
Recruit Status: No longer available
Study Type: Expanded Access
Official Title: A Randomized, Open-label Phase III Trial of Mapisal® Versus an Urea Hand-foot Cream as Prophylaxis for Capecitabine-induced Hand-foot Syndrome in Patients With Gastro
Brief Summary:
The purpose of this study is the examination of Mapisal® versus urea hand-foot cream as prophylaxis for capecitabine-induced hand-foot syndrome (HFS) in patients with gastrointestinal tumors or breast cancer, to assess the efficacy of Mapisal®.
Mapisal® is a medical device that is approved for the prophylaxis and treatment of HFS. Initial clinical data and case studies on the treatment and prophylaxis of Caelyx-induced HFS have been impressive. Because the pathomechanism of HFS caused by capecitabine is the same as for Caelyx-induced HFS, it is expected reason that administering Mapisal® should result in a significant reduction of HFS caused by capecitabine. The urea hand-foot cream was selected for the standard arm, because it is used commonly, is accepted by patients, and seems to have a positive influence on the severity of the HFS in the experience of many oncologists.