Clinical study evaluating the effect of a newly developed polaprezinc lozenge for prevention of chemotherapy-induced oral mucositis

2015 Fiscal Year Final Research Report

• Project/Area Number: 25460208
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical pharmacy
• Research Institution: Gifu University
• Principal Investigator: Itoh Yoshinori 岐阜大学, 医学(系)研究科(研究院), 教授 (50159927)
• Project Period (FY): 2013-04-01 – 2016-03-31
• Keywords: 口内炎 / 抗がん剤 / 造血幹細胞移植 / ポラプレジンク / トローチ / 含量均一性試験 / 安定性試験 / 製剤

Outline of Final Research Achievements

We developed for the first time a lozenge preparation containing polaprezinc (PZ), a zinc-L-carnosine. This preparation was stable and uniform after storage for up to 24 weeks, and applied to 16 patients receiving cancer chemotherapy before hematopoietic stem cell transplantation. The primary endpoint was the incidence of moderate to severe oral mucositis, while secondary endpoints were oral pain, xerostomia and taste disturbance. Oral mucositis occurred in 73% of patients without PZ treatment but in 13% of those who received PZ lozenge. PZ lozenge also reduced the incidence of oral pain, xerostomia and taste disturbance. Therefore, the present PZ lozenge was found to be highly effective for prevention of chemotherapy-induced oral mucositis.

Free Research Field

医療薬学