Clinical study evaluating the effect of a newly developed polaprezinc lozenge for prevention of chemotherapy-induced oral mucositis
| 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
|
| Project Status |
Completed (Fiscal Year 2015)
|
| Budget Amount *help |
¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2015: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2014: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2013: ¥2,730,000 (Direct Cost: ¥2,100,000、Indirect Cost: ¥630,000)
|
|---|
| 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 / トローチ製剤 / 放射線化学療法 / 頭頸部癌 / 臨床試験 / がん化学療法 |
|---|
| 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.
|
Report
(4 results)
Research Products
(9 results)
-
[Journal Article] Preparation and clinical evaluation of a novel lozenge containing polaprezinc, a zinc-L-carnosine, for prevention of oral mucositis in patients with hematological cancer who received high-dose chemotherapy.2016
Author(s)
Hayashi H, Kobayashi R, Suzuki A, Yamada Y, Ishida M, Syakui T, Kitagawa J, Hayasi H, Sugiyama T, Takeuchi H, Tsurumi H, Itoh Y.
-
Journal Title
European Journal of Pharmaceutics and Biopharmaceutics
Volume: submitted
Related Report
Peer Reviewed / Acknowledgement Compliant
-
[Journal Article] Effect of polaprezinc on oral mucositis, irradiation period, and time to discharge in patients with head and neck cancer.2016
Author(s)
Suzuki A, Kobayashi R, Shakui T, Kubota Y, Fukita M, Kuze B, Aoki M, Sugiyama T, Mizuta K, Itoh Y.
-
Journal Title
Head & Neck
Volume: in press
Issue: 9
Pages: 1387-1392
DOI
Related Report
Peer Reviewed / Acknowledgement Compliant
-
[Journal Article] Polaprezinc prevents oral mucositis in patients treated with high dose chemotherapy followed by hematopoietic stem cell transplantation2014
Author(s)
Hayashi H, Kobayashi R, Suzuki A, Ishihara M, Nakamura N, Kitagawa J, Kanemura N, Kasahara S, Kitaichi K, Hara T, Tsurumi H, Moriwaki H, Itoh Y
-
Journal Title
Anticancer Research
Volume: 34
Pages: 7271-7277
Related Report
Peer Reviewed / Open Access / Acknowledgement Compliant
-
-
-
-
-
-
