Toxicity Reduction with Antifungal Prophylaxis during Chemoradiotherapy for Head and Neck Cancer

• Project/Area Number: 19K17262
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 52040:Radiological sciences-related
• Research Institution: Niigata University
• Principal Investigator: 齋藤 紘丈 新潟大学, 医歯学総合病院, フルタイム医員 (90750315)
• Project Period (FY): 2019-04-01 – 2021-03-31
• Project Status: Discontinued (Fiscal Year 2020)
• Budget Amount: ¥4,030,000 (Direct Cost: ¥3,100,000、Indirect Cost: ¥930,000); Fiscal Year 2022: ¥390,000 (Direct Cost: ¥300,000、Indirect Cost: ¥90,000); Fiscal Year 2021: ¥130,000 (Direct Cost: ¥100,000、Indirect Cost: ¥30,000); Fiscal Year 2020: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000); Fiscal Year 2019: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
• Keywords: 口腔粘膜炎 / 倫理審査 / データマネジメント準備 / 後方視的研究 / 口腔咽頭カンジダ症

Outline of Research at the Start

頭頸部癌への化学放射線治療では重度の粘膜傷害が起こり食事摂取困難や生活の質の低下などの悪影響を及ぼす。口腔咽頭カンジダ症の合併は粘膜傷害を悪化させるため、その予防により粘膜傷害を軽減できると考えられる。後天性免疫不全症候群や造血幹細胞移植前の患者に抗真菌薬のフルコナゾールを予防投与することでカンジダ症が減少するため、頭頸部癌への化学放射線治療においても予防効果が期待できる。本研究は医師主導治験であり、頭頸部癌患者を対象として化学放射線治療に高用量のフルコナゾールを併用することが口腔咽頭カンジダ症と粘膜傷害の予防、ならびにQOLの維持に繋がるかを検証する。

Outline of Annual Research Achievements

2019年度は特定臨床研究「フルコナゾール投与による口腔粘膜炎の予防を目的とした臨床試験」の準備にあたり、臨床研究推進センターと共同でデータ入力システムの構築および論文作成を行った。2019年度末に研究代表者が精神疾患を発症し2020年度は研究活動を休止していた。2021年1月末をもって研究代表者が退職することとなり、廃止申請を行った。

Research Products

• [Journal Article] The association between oral candidiasis and severity of chemoradiotherapy-induced dysphagia in head and neck cancer patients: A retrospective cohort study (2020)
  • Author(s): Hirotake Saito, Ryusuke Shodo, Keisuke Yamazaki, Kouji Katsura, Yushi Uek, Toshimichi Nakano, Tomoya Oshikane, Nobuko Yamana, Satoshi Tanabe, Satoru Utsunomiya, Atsushi Ohta, Eisuke Abe, Motoki Kaidu, Ryuta Sasamoto, Hidefumi Aoyama
  • Journal Title: Clinical and Translational Radiation Oncology Volume: 20 Pages: 13-18
  • DOI: 10.1016/j.ctro.2019.10.006
  • Peer Reviewed / Open Access
• [Journal Article] The neurocognitive function change criteria after whole-brain radiation therapy for brain metastasis, in reference to healthrelated quality of life changes: a prospective observation study (2020)
  • Author(s): Toshimichi Nakano, Hidefumi Aoyama, Hirotake Saito, Satoshi Tanabe, Kensuke Tanaka, Katsuya Maruyama, Tomoya Oshikane, Atsushi Ohta, Eisuke Abe, Motoki Kaidu
  • Journal Title: BMC Cancer Volume: 20(1) Issue: 1 Pages: 66-76
  • DOI: 10.1186/s12885-020-6559-3
  • Peer Reviewed / Open Access
• [Journal Article] Selection criteria for 3D conformal radiotherapy versus volumetric-modulated arc therapy in highgrade glioma based on normal tissue complication probability of brain (2019)
  • Author(s): Satoshi Tanabe, Haruna Takahashi, Hirotake Saito, Atsushi Ohta, Toshimichi Nakano, Ryuta Sasamoto, Miki Shioi, Satoru Utsunomiya, Eisuke Abe, Motoki Kaidu, Hidefumi Aoyama
  • Journal Title: Journal of Radiation Research Volume: 60(2) Issue: 2 Pages: 249-256
  • DOI: 10.1093/jrr/rry106
  • Peer Reviewed / Open Access
• [Journal Article] Dramatic response of BRAF V600E-mutant epithelioid glioblastoma to combination therapy with BRAF and MEK inhibitor: establishment and xenograft of a cell line to predict clinical efficacy (2019)
  • Author(s): Kanemaru Yu、Natsumeda Manabu、Okada Masayasu、Saito Rie、Kobayashi Daiki、Eda Takeyoshi、Watanabe Jun、Saito Shoji、Tsukamoto Yoshihiro、Oishi Makoto、Saito Hirotake、Nagahashi Masayuki、Sasaki Takahiro、Hashizume Rintaro、Aoyama Hidefumi、Wakai Toshifumi、Kakita Akiyoshi、Fujii Yukihiko
  • Journal Title: Acta Neuropathologica Communications Volume: 7 Issue: 1 Pages: 119-119
  • DOI: 10.1186/s40478-019-0774-7
  • Peer Reviewed / Open Access / Int'l Joint Research