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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
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, hav...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Oxford University Press
2023
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10473272/ https://www.ncbi.nlm.nih.gov/pubmed/37340766 http://dx.doi.org/10.1093/jjco/hyad061 |
| _version_ | 1785100240719708160 |
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| author | Sadahiro, Ryoichi Hatta, Kotaro Yamaguchi, Takuhiro Masanori, Enokido Matsuda, Yoshinobu Ogawa, Asao Iwata, Yusei Tokoro, Akihiro Nakahara, Rika Hirayama, Takatoshi Yanai, Yuko Ogawa, Yuko Kayano, Ayako Ariyoshi, Keisuke Oyamada, Shunsuke Uchitomi, Yosuke Akechi, Tatsuo Yamamoto, Noboru Okita, Natsuko Yorikane, Eiko Shimada, Kazuaki Furukawa, Tetsuya Hashimoto, Hironobu Maeda, Makoto Sato, Tetsufumi Sekimoto, Asuko Sasaki, Chiyuki Saito, Eiko Uezono, Yasuhito Matsuoka, Hiromichi |
| author_facet | Sadahiro, Ryoichi Hatta, Kotaro Yamaguchi, Takuhiro Masanori, Enokido Matsuda, Yoshinobu Ogawa, Asao Iwata, Yusei Tokoro, Akihiro Nakahara, Rika Hirayama, Takatoshi Yanai, Yuko Ogawa, Yuko Kayano, Ayako Ariyoshi, Keisuke Oyamada, Shunsuke Uchitomi, Yosuke Akechi, Tatsuo Yamamoto, Noboru Okita, Natsuko Yorikane, Eiko Shimada, Kazuaki Furukawa, Tetsuya Hashimoto, Hironobu Maeda, Makoto Sato, Tetsufumi Sekimoto, Asuko Sasaki, Chiyuki Saito, Eiko Uezono, Yasuhito Matsuoka, Hiromichi |
| author_sort | Sadahiro, Ryoichi |
| collection | PubMed |
| description | 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. |
| format | Online Article Text |
| id | pubmed-10473272 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2023 |
| publisher | Oxford University Press |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-104732722023-09-02 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 Sadahiro, Ryoichi Hatta, Kotaro Yamaguchi, Takuhiro Masanori, Enokido Matsuda, Yoshinobu Ogawa, Asao Iwata, Yusei Tokoro, Akihiro Nakahara, Rika Hirayama, Takatoshi Yanai, Yuko Ogawa, Yuko Kayano, Ayako Ariyoshi, Keisuke Oyamada, Shunsuke Uchitomi, Yosuke Akechi, Tatsuo Yamamoto, Noboru Okita, Natsuko Yorikane, Eiko Shimada, Kazuaki Furukawa, Tetsuya Hashimoto, Hironobu Maeda, Makoto Sato, Tetsufumi Sekimoto, Asuko Sasaki, Chiyuki Saito, Eiko Uezono, Yasuhito Matsuoka, Hiromichi Jpn J Clin Oncol Clinical Trial Note 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. Oxford University Press 2023-06-20 /pmc/articles/PMC10473272/ /pubmed/37340766 http://dx.doi.org/10.1093/jjco/hyad061 Text en © The Author(s) 2023. Published by Oxford University Press. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
| spellingShingle | Clinical Trial Note Sadahiro, Ryoichi Hatta, Kotaro Yamaguchi, Takuhiro Masanori, Enokido Matsuda, Yoshinobu Ogawa, Asao Iwata, Yusei Tokoro, Akihiro Nakahara, Rika Hirayama, Takatoshi Yanai, Yuko Ogawa, Yuko Kayano, Ayako Ariyoshi, Keisuke Oyamada, Shunsuke Uchitomi, Yosuke Akechi, Tatsuo Yamamoto, Noboru Okita, Natsuko Yorikane, Eiko Shimada, Kazuaki Furukawa, Tetsuya Hashimoto, Hironobu Maeda, Makoto Sato, Tetsufumi Sekimoto, Asuko Sasaki, Chiyuki Saito, Eiko Uezono, Yasuhito Matsuoka, Hiromichi 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Clinical Trial Note |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10473272/ https://www.ncbi.nlm.nih.gov/pubmed/37340766 http://dx.doi.org/10.1093/jjco/hyad061 |
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