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. 2023 Aug 30;53(9):851-857.
doi: 10.1093/jjco/hyad061.

A multi-centre, double-blind, randomized, placebo-controlled trial to evaluate the effectiveness and safety of ramelteon for the prevention of postoperative delirium in elderly cancer patients: a study protocol for JORTC-PON2/J-SUPPORT2103/NCCH2103

Ryoichi Sadahiro  1 , Kotaro Hatta  2 , Takuhiro Yamaguchi  3 , Enokido Masanori  4 , Yoshinobu Matsuda  5 , Asao Ogawa  4 , Yusei Iwata  4 , Akihiro Tokoro  5 , Rika Nakahara  1 , Takatoshi Hirayama  1 , Yuko Yanai  1 , Yuko Ogawa  1 , Ayako Kayano  1 , Keisuke Ariyoshi  6 , Shunsuke Oyamada  6 , Yosuke Uchitomi  7 , Tatsuo Akechi  8 , Noboru Yamamoto  9 , Natsuko Okita  10 , Eiko Yorikane  10 , Kazuaki Shimada  11 , Tetsuya Furukawa  12 , Hironobu Hashimoto  12 , Makoto Maeda  12 , Tetsufumi Sato  13 , Asuko Sekimoto  14 , Chiyuki Sasaki  14 , Eiko Saito  15 , Yasuhito Uezono  16 , Hiromichi Matsuoka  1
Affiliations

A multi-centre, double-blind, randomized, placebo-controlled trial to evaluate the effectiveness and safety of ramelteon for the prevention of postoperative delirium in elderly cancer patients: a study protocol for JORTC-PON2/J-SUPPORT2103/NCCH2103

Ryoichi Sadahiro et al. Jpn J Clin Oncol. .

Abstract

Postoperative delirium is an important issue in cancer patients, affecting surgical outcomes and the quality of life. Ramelteon is a melatonin receptor agonist with high affinity for MT1 and MT2 receptors. Clinical trials and observational studies in Japan, including in surgical cancer patients, have shown efficacy of ramelteon in delirium prevention, with no serious safety concerns. However, clinical trials from the USA have reported conflicting results. A Japanese phase II study investigated the efficacy and safety of ramelteon for delirium prevention following gastrectomy in patients aged ≥75 years, with findings suggesting the feasibility of a phase III trial. The aim of this multi-centre, double-blind, randomized placebo-controlled phase III trial is to evaluate the effectiveness and safety of oral ramelteon for postoperative delirium prevention in cancer patients aged ≥65 years as advanced medical care. The trial protocol is described here.

Keywords: cancer; delirium; ramelteon; randomized controlled trial.

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Conflict of interest statement

Although not directly related to the study, to disclose any potential financial conflicts of interest we acknowledge that Dr Ryoichi Sadahiro reports receiving grants from SGH foundation and honoraria from Meiji, Takeda and Merck & Co. Dr Kotaro Hatta has received lecture honoraria for Sumitomo, Eisai, Janssen, Meiji Seika, MSD and Otsuka within the past 3 years. Dr Takuhiro Yamaguchi reports receiving grants from AC MEDICAL INC., A2 Healthcare Corporation, ClinChoice, Japan Media Corporation, Kyowa Kirin Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Medrio, Inc., Welby Inc., 3H Medi Solution Inc., Baseconnect Inc., Nobori Ltd., Puravida Technologies LLC., Hemp Kitchen Inc., Solasia Pharma K.K. and Cordis Corporation; personal fees from Chugai Pharmaceutical Co., Ltd., Kasei Pharma Corporation, Takeda, SONIRE Therapeutics Inc., AstraZeneca, Merck and Co., Inc., EPS Corporation, Kowa Company, Ltd., TSUMURA & CO., 3H Clinical Trial Inc., Incyte Biosciences Japan and SEIKAGAKU CORPORATION; and grants and personal fees from Intellim Corporation, Japan Tobacco Inc., Medidata Solutions, Inc., ONO PHARMACEUTICAL CO., LTD., DAIICHI SANKYO COMPANY, LIMITED., Eisai Co., Ltd., ASAHI INTECC CO., LTD. and NIPRO CORPORATION outside the submitted work. Dr Yoshinobu Matsuda has received lectures fees from Hisamitsu Pharmaceutical Co., Inc., Fujimoto Pharmaceutical Corporation, Takeda Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd. and Chugai Pharmaceutical Co., Ltd.. Dr Shunsuke Oyamada reports receiving honoraria from Chugai Co. Dr Tatsuo Akechi reports receiving lectures fees from Chugai, Daiichi-Sankyo, Eizai, Janssen, Kyowa Kirin, Eli Lilly, MSD, Meiji-Seika Pharma, Mochida, Nipro, Nihon zoki, Otsuka, Pfizer, Sumitomo pharma, Takeda and Viatris and royalties from Igaku-Shoin. Dr Tatsuo Akechi has patents, royalties, other intellectual property: the inventor of the pending patents (2020-135195, 2022-069057) (Institute). Dr Noboru Yamamoto reports receiving grants from Astellas, Chugai, Eisai, Taiho, BMS, Pfizer, Novartis, Eli Lilly, AbbVie, Daiichi-Sankyo, Bayer, Boehringer Ingelheim, Kyowa-Hakko Kirin, Takeda, ONO, Janssen Pharma, MSD, MERCK, GSK, Sumitomo Dainippon, Chiome Bioscience, Otsuka, Carna Biosciences, Genmab, Shionogi, TORAY, KAKEN, CMIC; honoraria as a speaker from ONO, Chugai, Daiichi-Sankyo, Eisai; and having advisory roles for Eisai, Takeda, Otsuka, Boehringer Ingelheim, CMIC and Chugai.

Figures

Figure 1
Figure 1
Flowchart of the study procedure.
See this image and copyright information in PMC

References

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