Efficacy of uracil ointment for capecitabine induced hand-foot syndrome

2014 Fiscal Year Final Research Report

• Project/Area Number: 23591903
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: General surgery
• Research Institution: Kyoto Prefectural University of Medicine
• Principal Investigator: TAGUCHI Tetsuya 京都府立医科大学, 医学(系)研究科(研究院), 教授 (80243260)
• Co-Investigator(Kenkyū-buntansha): SAKAGUCHI Koichi 京都府立医科大学, 大学院医学研究科, 助教 (00405284)
• Project Period (FY): 2011-04-28 – 2015-03-31
• Keywords: 化学療法 / 副作用 / 皮膚障害 / 手足症候群 / カペシタビン / 分子標的薬 / ウラシル / 軟膏

Outline of Final Research Achievements

We attempted to develop the ointment prevents hand-foot syndrome (HFS) induced by capecitabine (CAP). We developed 3% uracil containing ointment (UO), which possibly inhibits the production of metabolites of CAP.
At first, phase I trail was performed. As a result, 3% UO is safe and unchanging blood concentration of uracil seems UO will not block the treatment effect of CAP. Based on PI trial, we carried out phase II trial that assess the efficacy and safety of UO. Metastatic breast cancer patients were eligible for enrolement, and were treated with q3w CAP, concurrently with application of 3% UO on the palms and the soles of the subjects. As a result, the frequency at the second and the third cycle was 35.3% and 50%, respectively. According to the investigational phase II trial of CAP in Japan, frequency of grade 2 HFS was 75.3%. Thus, our 3% UO might be effective in the prevention of HFS induced by CAP. But to confirm the clinical benefit of UO, RCT may be required in the future.

Free Research Field

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