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Randomized clinical trial on the effect of oral care on the prevention of severe radiation-induced oral mucositis

Research Project

Project/Area Number 26463018
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Surgical dentistry
Research InstitutionNagasaki University

Principal Investigator

UMEDA Masahiro  長崎大学, 医歯薬学総合研究科(歯学系), 教授 (60301280)

Co-Investigator(Kenkyū-buntansha) 栗田 浩  信州大学, 学術研究院医学系, 教授 (10273103)
大倉 正也  大阪大学, 歯学研究科, 准教授 (10281130)
川下 由美子  長崎大学, 病院(歯学系), 助教 (10304958)
古森 孝英  神戸大学, 医学研究科, 教授 (50251294)
太田 嘉英  東海大学, 医学部, 教授 (60233152)
桐田 忠昭  奈良県立医科大学, 医学部, 教授 (70201465)
Project Period (FY) 2014-04-01 – 2017-03-31
Project Status Completed (Fiscal Year 2016)
Budget Amount *help
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2016: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2015: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2014: ¥2,860,000 (Direct Cost: ¥2,200,000、Indirect Cost: ¥660,000)
Keywords放射線性口内炎 / 口腔管理 / 予防 / ランダム化比較試験 / 口腔癌 / 放射線治療 / 口内炎 / 口腔粘膜炎 / 口腔がん / 口腔ケア / ランダム化
Outline of Final Research Achievements

Severe oral mucositis often occurs in patients who undergo radiotherapy (RT) or chemo-radiotherapy (CRT) to the oral region. The aim to the study is to investigate the effectiveness of oral management on development of grade 3 oral mucositis in patients with oral cancer undergoing RT by a multicenter, randomized clinical trial. A total of 88 patients were enrolled in the study, and randomly divided into the intervention and the control group. Patients in the intervention group received spacer, administration of pilocarpine and dexamethasone ointment. Various demographic, tumor-related, and treatment-related factors were examined. The primary endpoint is development of grade 3 oral mucositis. Oral care intervention did not prevent grade 3 oral mucositis in all 88 patients. However, when patients were divided into RT and CCRT groups, the occurrence rate of grade 3 mucositis was significantly lower in the oral care group than that in the control group in patients undergoing RT alone.

Report

(4 results)
  • 2016 Annual Research Report   Final Research Report ( PDF )
  • 2015 Research-status Report
  • 2014 Research-status Report
  • Research Products

    (2 results)

All 2015

All Presentation (2 results)

  • [Presentation] 口腔に放射線治療を受ける患者への口腔粘膜炎予防方法に関する多施設共同前向き研究-中間報告-2015

    • Author(s)
      川下由美子、梅田正博
    • Organizer
      頭頸部癌学会
    • Place of Presentation
      神戸国際会議場(神戸市中央区)
    • Year and Date
      2015-06-11 – 2015-06-12
    • Related Report
      2014 Research-status Report
  • [Presentation] 口腔癌放射線治療患者における口腔粘膜炎予防方法に関する多施設共同前向き研究(JOOG 1301)中間報告2015

    • Author(s)
      川下由美子、梅田正博、他
    • Organizer
      第39回頭頸部癌学会
    • Place of Presentation
      神戸国際会議場(神戸市)
    • Year and Date
      2015-06-04
    • Related Report
      2015 Research-status Report

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Published: 2014-04-04   Modified: 2018-03-22  

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