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Use of duloxetine after pregabalin administration to neuropathic pain in cancer patients

Research Project

Project/Area Number 26860486
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field General internal medicine(including psychosomatic medicine)
Research InstitutionKindai University

Principal Investigator

MATSUOKA Hiromichi  近畿大学, 医学部附属病院, 講師 (20425078)

Project Period (FY) 2014-04-01 – 2018-03-31
Project Status Completed (Fiscal Year 2017)
Budget Amount *help
¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
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: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Keywordsがん患者 / 神経障害性疼痛 / デュロキセチン / プラセボ / RCT / プラセボ対照RCT / 緩和医療 / 心身医学 / プラセボ対照ダブルブラインドRCT
Outline of Final Research Achievements

A protocol paper of the second line trial was published in BMJ Open (August 2017), cooperated with the research sharing organization, completed the case collection at the end of November 2017, and fixing and analyzing data was completed at the data center by March 2018. We registered an abstract of this study to the American Society of Clinical Oncology (ASCO) in 2018 and the 23rd Congress of the Japanese Society for Palliative Medicine. The theme was adopted by both academic societies and was selected as an excellent award for the 23rd Congress of the Japanese Society for Palliative Medicine. In the double-blind randomized placebo-controlled study described here, we will evaluate the efficacy of addition of duloxetine for neuropathic cancer pain refractory to opioids and gabapentinoids. The results of the trial will clarify the second-line standard treatment for cancer-related NP. Therefore, we plan to perform a head-to head RCT of duloxetine and gabapentinoids.

Report

(5 results)
  • 2017 Annual Research Report   Final Research Report ( PDF )
  • 2016 Research-status Report
  • 2015 Research-status Report
  • 2014 Research-status Report
  • Research Products

    (9 results)

All 2018 2017 2016 2015

All Journal Article (1 results) (of which Peer Reviewed: 1 results,  Open Access: 1 results) Presentation (8 results) (of which Int'l Joint Research: 5 results)

  • [Journal Article] Study protocol for a multi-institutional, randomised, double-blinded, placebo-controlled phase III trial investigating additive efficacy of duloxetine for neuropathic cancer pain refractory to opioids and gabapentinoids: the DIRECT study.2017

    • Author(s)
      Matsuoka H, Ishiki H, Iwase S, Koyama A, Kawaguchi T, Kizawa Y, Morita T, Matsuda Y, Miyaji T, Ariyoshi K, Yamaguchi T.
    • Journal Title

      BMJ Open

      Volume: 28 Issue: 8 Pages: e017280-e017280

    • DOI

      10.1136/bmjopen-2017-017280

    • NAID

      120006373800

    • Related Report
      2017 Annual Research Report
    • Peer Reviewed / Open Access
  • [Presentation] A Multi-center, Randomized, Double-blinded, Placebo-controlled Trial of Additive Effect of Duloxetine for Neuropathic Cancer Pain Refractory to Opioids and Gabapentinoids: JORTC- PAL08 (DIRECT study)2018

    • Author(s)
      Eriko Satomi, Hiromichi Matsuoka et al.
    • Organizer
      米国癌治療学会
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] がん患者の神経障害性疼痛に対するデュロキセチンの有用性: 検証的無作為化二重盲検プラセボ比較試験(JORTC-PAL08試験、DIRECT Study)2018

    • Author(s)
      蓮尾英明、松岡弘道ら
    • Organizer
      第23回日本緩和医療学会総会
    • Related Report
      2017 Annual Research Report
  • [Presentation] Efficacy and safety of pregabalin and duloxetine for neuropathic cancer pain refractory to opioids: A Randomised Controlled Trial2017

    • Author(s)
      Hiromichi Matsuoka
    • Organizer
      9th PaCCSC annual meeting
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Efficacy of the addition of duloxetine for neuropathic cancer pain refractory to opioids and gabapentinoids: a randomized, double-blind, placebo-controlled trial (JORTC Pal08 DIRECT Trial)2017

    • Author(s)
      Hiromichi Matsuoka
    • Organizer
      14th Austaralia Palliative Care Conference
    • Related Report
      2017 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Efficacy of the addition of duloxetine for neuropathic cancer pain refractory to opioids and gabapentinoids: a double-blind, randomized, placebo-controlled trial2017

    • Author(s)
      Hiromichi Matsuoka
    • Organizer
      8th PACCSC Annual Forum
    • Place of Presentation
      シドニー(オーストラリア)
    • Related Report
      2016 Research-status Report
    • Int'l Joint Research
  • [Presentation] がん患者の神経障害性疼痛へのデュロキセチンの効果:Trials in Progress2016

    • Author(s)
      松岡 弘道
    • Organizer
      第21回日本心療内科学会総会・学術大会
    • Place of Presentation
      奈良春日野国際フォーラム(奈良県奈良市)
    • Year and Date
      2016-12-03
    • Related Report
      2016 Research-status Report
  • [Presentation] 多施設共同ランダム化比較試験がもたらす心身医学の未来2016

    • Author(s)
      松岡弘道
    • Organizer
      第57回日本心身医学会総会ならびに学術講演会
    • Place of Presentation
      仙台国際センター(宮城県仙台市)
    • Year and Date
      2016-06-04
    • Related Report
      2016 Research-status Report
  • [Presentation] Efficacy of Duloxetine for Cancer Patients with Neuropathic Pain Non- responsive to Pregabalin2015

    • Author(s)
      松岡 弘道
    • Organizer
      TheICPM23rdWorldCongress(第23回心身医学会世界会議)
    • Place of Presentation
      イギリス(グラスゴー)
    • Year and Date
      2015-08-19
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research

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Published: 2014-04-04   Modified: 2020-01-20  

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