the Treatment Hand-foot Syndrome Patients With Gastrointestinal Tumors or Breast Cancer, Who Are Treated With Capecitabine Clinical Trial
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 Gastrointestinal Tumors or Breast Cancer
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.
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.
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