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Development of evidence-based standard drug therapy for refractory neuropathic cancer pain

Research Project

Project/Area Number 17K09336
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field General internal medicine(including psychosomatic medicine)
Research InstitutionNational Cancer Center Japan (2020)
Kindai University (2017-2019)

Principal Investigator

Matsuoka Hiromichi  国立研究開発法人国立がん研究センター, 中央病院, 科長 (20425078)

Co-Investigator(Kenkyū-buntansha) 岩瀬 哲  埼玉医科大学, 医学部, 教授 (60372372)
Project Period (FY) 2017-04-01 – 2021-03-31
Project Status Completed (Fiscal Year 2020)
Budget Amount *help
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2020: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2019: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2018: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2017: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Keywords神経障害性疼痛 / デュロキセチン / プレガバリン / 国際多施設共同二重盲検比較試験 / プラセボ対照ダブルブラインドRCT / 緩和医療 / 心身医学
Outline of Final Research Achievements

The results of "A randomized, double-blind, placebo-controlled trial of gabapentin derivatives in refractory and intolerant patients" were published in an international journal (Matsuoka et al. BMJ Open 2017, Journal of Pain and Symptom Management 2019, Supportive Care in Cancer 2020).
"A Phase III, international, multi-centre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin over 14 days for opioid unresponsive cancer-related neuropathic pain" has been initiated, and enrollment of 32 patients/100 has been completed.

Academic Significance and Societal Importance of the Research Achievements

オピオイド・プレガバリンに不応、不耐のがん患者の難治性神経障害性疼痛に対する標準治療はなく、アンメットメディカルニーズである。今回の研究結果から、オピオイド・プレガバリン使用後の2次治療としてのデュロキセチンの有効性と安全性に対する知見を得て、有効な対象患者(チクチクした痛み)に対しての今後の可能性を示した。今後緩和医療最先端国家の一つである豪州との連携を強め、臨床研究体制の構築を行っていく。

Report

(5 results)
  • 2020 Annual Research Report   Final Research Report ( PDF )
  • 2019 Research-status Report
  • 2018 Research-status Report
  • 2017 Research-status Report
  • Research Products

    (22 results)

All 2020 2019 2018 2017 Other

All Int'l Joint Research (3 results) Journal Article (8 results) (of which Int'l Joint Research: 1 results,  Peer Reviewed: 8 results,  Open Access: 4 results) Presentation (11 results) (of which Int'l Joint Research: 8 results,  Invited: 1 results)

  • [Int'l Joint Research] University Technology Sydney(オーストラリア)

    • Related Report
      2020 Annual Research Report
  • [Int'l Joint Research] University of Technology Sydney(オーストラリア)

    • Related Report
      2019 Research-status Report
  • [Int'l Joint Research] University of Technology Sydney(オーストラリア)

    • Related Report
      2018 Research-status Report
  • [Journal Article] Predictors of duloxetine response in patients with neuropathic cancer pain: a secondary analysis of a randomized controlled trial-JORTC-PAL08 (DIRECT) study2020

    • Author(s)
      Matsuoka H, Otani H, et al.
    • Journal Title

      Support Care Cancer

      Volume: 28 Issue: 6 Pages: 2931-2939

    • DOI

      10.1007/s00520-019-05138-9

    • Related Report
      2020 Annual Research Report 2019 Research-status Report
    • Peer Reviewed
  • [Journal Article] The current clinical use of adjuvant analgesics for refractory cancer pain in Japan: a nationwide cross-sectional survey2020

    • Author(s)
      Tagami Keita、Matsuoka Hiromichi、Ariyoshi Keisuke、Oyamada Shunsuke、Hiratsuka Yusuke、Kizawa Yoshiyuki、Koyama Atsuko、Inoue Akira
    • Journal Title

      Japanese Journal of Clinical Oncology

      Volume: 50 Issue: 12 Pages: 1434-1441

    • DOI

      10.1093/jjco/hyaa147

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Between-group difference in mean values or changes in pain intensity? Evaluating the distribution of change from baseline in a neuropathic cancer pain clinical trial.2020

    • Author(s)
      Matsuoka H, Morita T, Oyamada S, Yamaguchi T, Koyama A.
    • Journal Title

      Ann Palliat Med.

      Volume: 9 Issue: 6 Pages: 4398-4402

    • DOI

      10.21037/apm-20-930

    • Related Report
      2020 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Additive Duloxetine for Cancer-Related Neuropathic Pain Nonresponsive or Intolerant to Opioid-Pregabalin Therapy: A Randomized Controlled Trial (JORTC-PAL08).2019

    • Author(s)
      Matsuoka H, Iwase S, Miyaji T, Kawaguchi T, Ariyoshi K, Oyamada S, Satomi E, Ishiki H, Hasuo H, Sakuma H, Tokoro A, Shinomiya T, Otani H, Ohtake Y, Tsukuura H, Matsumoto Y, Hasegawa Y, Kataoka Y, Otsuka M, Sakai K, Matsuda Y, Morita T, Koyama A, Yamaguchi T.
    • Journal Title

      J Pain Symptom Manage

      Volume: 58 Issue: 4 Pages: 645-653

    • DOI

      10.1016/j.jpainsymman.2019.06.020

    • Related Report
      2019 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Harms From Haloperidol for Symptom Management in Palliative Care-a Post Hoc Pooled Analysis of Three Randomized Controlled Studies and Two Consecutive Cohort Studies.2019

    • Author(s)
      Matsuoka H, Agar M, Vandersman Z, Good P, Fazekas B, Brown L, Hardy J, Weil J, Currow DC.
    • Journal Title

      J Pain Symptom Manage.

      Volume: 58 Issue: 3 Pages: e6-e8

    • DOI

      10.1016/j.jpainsymman.2019.05.004

    • Related Report
      2019 Research-status Report
    • Peer Reviewed
  • [Journal Article] Attitude of Japanese palliative care specialists towards adjuvant analgesics cancer-related neuropathic pain refractory to opioid therapy: a nationwide cross-sectional survey.2019

    • Author(s)
      Matsuoka H, Tagami K, Ariyoshi K, Oyamada S, Kizawa Y, Inoue A, Koyama A.
    • Journal Title

      Jpn J Clin Oncol

      Volume: 49 Issue: 5 Pages: 486-490

    • DOI

      10.1093/jjco/hyz002

    • Related Report
      2019 Research-status Report 2018 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Comparability of the Australian National Cancer Symptom Trials (CST) Group's Study Populations to National Referrals to Non-CST Specialist Palliative Care Services Participating in the Palliative Care Outcomes Collaboration.2019

    • Author(s)
      Matsuoka H, Allingham S, Fazekas B, Brown L, Vandersman Z, Clark K, Agar MR, Currow DC.
    • Journal Title

      J Pain Symptom Manage.

      Volume: 57 Issue: 1 Pages: e9-e14

    • DOI

      10.1016/j.jpainsymman.2018.09.017

    • Related Report
      2018 Research-status Report
    • Peer Reviewed / Int'l Joint Research
  • [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 Research-status Report
    • Peer Reviewed / Open Access
  • [Presentation] がん疼痛に対する鎮痛補助薬を化学的に究明する2020

    • Author(s)
      松岡弘道
    • Organizer
      緩和・支持・心のケア合同学術大会2020
    • Related Report
      2020 Annual Research Report
  • [Presentation] Updates on the management of neuropathic pain in cancer patients2019

    • Author(s)
      Matsuoka Hiromichi
    • Organizer
      13th Asia Pacific Hospice Conference
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] A Phase III, international, multi-centre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin over 14 days for opioid unresponsive cancer-related neuropathic pain.2019

    • Author(s)
      Hiromichi Matsuoka et al.
    • Organizer
      10th PaCCSC annual meeting(国際学会)
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research
  • [Presentation] 神経障害性疼痛に対するデュロキセチンの効果:2018

    • Author(s)
      Hiromichi Matsuoka et al.
    • Organizer
      癌治療学会
    • Related Report
      2018 Research-status Report
  • [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(ASCO)
    • Related Report
      2018 Research-status 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
      2018 Research-status Report 2017 Research-status Report
  • [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)
      Hiromichi Matsuoka et al.
    • Organizer
      豪州臨床腫瘍学会(COSA)
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research
  • [Presentation] Comparability of the Australian National Cancer Symptom2018

    • Author(s)
      hHiromichi Matsuoka et al.
    • Organizer
      ASCO PalliativeCare in Oncology
    • Related Report
      2018 Research-status Report
    • Int'l Joint Research
  • [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
      2018 米国癌治療学会(ASCO)
    • Related Report
      2017 Research-status Report
    • Int'l Joint Research
  • [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 Research-status Report
    • Int'l Joint Research
  • [Presentation] 2.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 Research-status Report
    • Int'l Joint Research

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Published: 2017-04-28   Modified: 2022-01-27  

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