Prophylactic effect of a novel lozenge containing polaprezinc, a zinc-L-carnosine, against chemotherapy-induced oral mucositis in cancer therapy
| Project/Area Number |
17K08440
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical pharmacy
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| Research Institution | Gifu University |
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Principal Investigator |
Akio Suzuki 岐阜大学, 医学部附属病院, 准教授 (80775148)
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| Co-Investigator(Kenkyū-buntansha) |
林 秀樹 岐阜薬科大学, 薬学部, 准教授 (00419665)
小林 亮 岐阜大学, 大学院医学系研究科, 非常勤講師 (50555662)
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| Project Period (FY) |
2017-04-01 – 2020-03-31
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| Project Status |
Completed (Fiscal Year 2019)
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| Budget Amount *help |
¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
Fiscal Year 2019: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2018: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2017: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
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| Keywords | 口内炎 / ポラプレジンク / がん化学療法 / 造血幹細胞移植 / 有害事象 / QOL / 化学療法 / 血液腫瘍 / 口腔内適用製剤 / 造血幹細胞移植前大量化学療法 / 多施設共同無作為化比較試験 / 小児 / 癌 / 放射線治療 |
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| Outline of Final Research Achievements |
Oral mucositis is one of the most common and debilitating complication of cancer treatment, particularly chemotherapy and radiotherapy. We previously reported that oral ingestion of polaprezinc suspended in sodium alginate solution prevents oral mucositis in cancer treatment. In the present study, we developed a novel preparation of polaprezinc and evaluated clinical effect of the lozenge preparation in patients receiving cancer therapy.The preparation contained 18.75 mg polaprezinc in a tablet. We carried out a multi-institutional prospective randomized controlled study. polaprezinc lozenges were effective for prophylaxis against Grade ≧2 oral mucositis associated with chemotherapy in patients undergoing hematopoietic stem cell transplantation.
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| Academic Significance and Societal Importance of the Research Achievements |
本研究では、PZトローチの口内炎に対する予防効果を多施設共同の前向き無作為化比較試験により明らかにした。国内においては、口内炎に対して有効性が認められた薬剤は承認されていない。海外では、paliferminが唯一、造血幹細胞移植前の大量化学療法による口内炎への適応が米国FDAにて承認されている。しかし、小児患者に対しては、長期安全性の観点から推奨度は低い。PZは小児患者においても有効性が示されている。重篤な口内炎の発現はがん治療の治療効果を低下させる要因となることが明らかとなっており、本研究結果は、がん治療によ伴う口内炎によるQOLの維持及び治療効果の向上に大きく貢献できるものと考える。
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Report
(4 results)
Research Products
(15 results)
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[Journal Article] Real-world data of the association between quality of life using the EuroQol 5 Dimension 5 Level utility value and adverse events for outpatient cancer chemotherapy2020
Author(s)
Hirose C, Fujii H, Iihara H, Ishihara M, Nawa-Nishigaki M, Kato-Hayashi H, Ohata K, Kumiko Sekiya K, Kitahora M, Matsuhashi N, Takahashi T, Okuda K, Naruse M, Ishihara T, Sugiyama T, Yoshida K, Suzuki A
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Journal Title
Supportive Care in Cancer
Volume: -
Issue: 12
Pages: 5943-5952
DOI
Related Report
Peer Reviewed / Open Access
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[Journal Article] Prophylactic Effect of Polaprezinc, a Zinc-L-carnosine, Against Chemotherapy-induced Oral Mucositis in Pediatric Patients Undergoing Autologous Stem Cell Transplantation.2018
Author(s)
Funato M, Ozeki M, Suzuki A, Ishihara M, Kobayashi R, Nozawa A, Yasue S, Endo-Ohnishi S, Fukao T, Itoh Y
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Journal Title
Anticancer Res.
Volume: 38
Issue: 8
Pages: 4691-4697
DOI
Related Report
Peer Reviewed / Open Access
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[Journal Article] Improvement of Dysgeusia by Polaprezinc, a Zinc-L-carnosine, in Outpatients Receiving Cancer Chemotherapy.2018
Author(s)
Fujii H, Hirose C, Ishihara M, Iihara H, Imai H, Tanaka Y, Matsuhashi N, Takahashi T, Yamaguchi K, Yoshida K, Suzuki A
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Journal Title
Anticancer Res.
Volume: 38
Issue: 11
Pages: 6367-6373
DOI
Related Report
Peer Reviewed / Open Access
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