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 Gastrointestinal Tumors or Breast Cancer (PROCAPP)

Device: Mapisal
Mapisal® ointment will be applied to hand and feet three times daily, as well as after washing hands. Treatment should start 2 days prior to the first chemotherapy cycle with capecitabine and will continue daily for the first 6 weeks of chemotherapy.
Other: Urea hand-foot cream
Urea hand-foot cream will be applied to hand and feet three times daily, as well as after washing hands. Treatment should start 2 days prior to the first chemotherapy cycle with capecitabine and will continue daily for the first 6 weeks of chemotherapy.

Hand-foot syndrome (HFS) is a frequently occurring, often dose limiting, dermatologic reaction associated with cytotoxic agents, such as capecitabine, liposomal doxorubicin, and doxetacel.

Adverse events affecting the integument have posed significant challenges to oncologists in recent years in terms of selecting appropriate supportive therapies. Not only medications that inhibit EGFR receptors such as erlotinib, gefitinib, panitumumab or cetuximab, but also multiple-receptor tyrosine kinase inhibitors such as sunitinib and sorafenib and other "older" medications such as capecitabine can often lead to skin-related adverse events that can be difficult to manage.

These adverse events compromise skin-related quality of life and can lead to dose compromises or even the termination of treatment.

To date, there are no side effects reported for the use of either Mapisal® or urea hand-foot cream, making both treatments safe. Given the potential benefits of the treatments in preventing HFS by reducing discomfort and impairment of quality of life, the conduct of the trial is regarded as justifiable and there is no indication that patients are exposed to an increased risk associated with study participation.