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
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 pati...
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| Veröffentlicht in: | Japanese journal of clinical oncology 2023-08, Vol.53 (9), p.851-857 |
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| container_title | Japanese journal of clinical oncology |
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| creator | 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 |
| description | 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.
This paper describes the protocol of a multi-centre, double-blind, randomized placebo-controlled trial evaluating the effectiveness and safety of oral ramelteon for postoperative delirium prevention in cancer patients aged ≥65 years. |
| doi_str_mv | 10.1093/jjco/hyad061 |
| format | Article |
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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.
This paper describes the protocol of a multi-centre, double-blind, randomized placebo-controlled trial evaluating the effectiveness and safety of oral ramelteon for postoperative delirium prevention in cancer patients aged ≥65 years.</description><identifier>ISSN: 1465-3621</identifier><identifier>ISSN: 0368-2811</identifier><identifier>EISSN: 1465-3621</identifier><identifier>DOI: 10.1093/jjco/hyad061</identifier><identifier>PMID: 37340766</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Clinical Trial Note</subject><ispartof>Japanese journal of clinical oncology, 2023-08, Vol.53 (9), p.851-857</ispartof><rights>The Author(s) 2023. Published by Oxford University Press. 2023</rights><rights>The Author(s) 2023. Published by Oxford University Press.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c398t-e22fed1fd77a1ff589bab6e03b161361fb305d0420cad9414ba626b2707c72143</cites><orcidid>0000-0001-5092-9377 ; 0000-0002-7276-1971 ; 0000-0002-0787-2851 ; 0000-0003-1764-1763</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,1578,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37340766$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sadahiro, Ryoichi</creatorcontrib><creatorcontrib>Hatta, Kotaro</creatorcontrib><creatorcontrib>Yamaguchi, Takuhiro</creatorcontrib><creatorcontrib>Masanori, Enokido</creatorcontrib><creatorcontrib>Matsuda, Yoshinobu</creatorcontrib><creatorcontrib>Ogawa, Asao</creatorcontrib><creatorcontrib>Iwata, Yusei</creatorcontrib><creatorcontrib>Tokoro, Akihiro</creatorcontrib><creatorcontrib>Nakahara, Rika</creatorcontrib><creatorcontrib>Hirayama, Takatoshi</creatorcontrib><creatorcontrib>Yanai, Yuko</creatorcontrib><creatorcontrib>Ogawa, Yuko</creatorcontrib><creatorcontrib>Kayano, Ayako</creatorcontrib><creatorcontrib>Ariyoshi, Keisuke</creatorcontrib><creatorcontrib>Oyamada, Shunsuke</creatorcontrib><creatorcontrib>Uchitomi, Yosuke</creatorcontrib><creatorcontrib>Akechi, Tatsuo</creatorcontrib><creatorcontrib>Yamamoto, Noboru</creatorcontrib><creatorcontrib>Okita, Natsuko</creatorcontrib><creatorcontrib>Yorikane, Eiko</creatorcontrib><creatorcontrib>Shimada, Kazuaki</creatorcontrib><creatorcontrib>Furukawa, Tetsuya</creatorcontrib><creatorcontrib>Hashimoto, Hironobu</creatorcontrib><creatorcontrib>Maeda, Makoto</creatorcontrib><creatorcontrib>Sato, Tetsufumi</creatorcontrib><creatorcontrib>Sekimoto, Asuko</creatorcontrib><creatorcontrib>Sasaki, Chiyuki</creatorcontrib><creatorcontrib>Saito, Eiko</creatorcontrib><creatorcontrib>Uezono, Yasuhito</creatorcontrib><creatorcontrib>Matsuoka, Hiromichi</creatorcontrib><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><title>Japanese journal of clinical oncology</title><addtitle>Jpn J Clin Oncol</addtitle><description>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.
This paper describes the protocol of a multi-centre, double-blind, randomized placebo-controlled trial evaluating the effectiveness and safety of oral ramelteon for postoperative delirium prevention in cancer patients aged ≥65 years.</description><subject>Clinical Trial Note</subject><issn>1465-3621</issn><issn>0368-2811</issn><issn>1465-3621</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><recordid>eNp9ks9v0zAUxyMEYmNw44x8g0ND_SNxUi5oqoAxTWsF2zly7GfqyomD7VQqfzlHnLZM48LJz36f97FlfbPsNcHvCV6w-XYr3XyzFwpz8iQ7JwUvc8YpefqoPstehLDFGJd1UT3PzljFClxxfp79vkTdaKPJJfTRwwwpN7YW8taaXs2QF71ynfkFqR6skNC6XLpEOmtBoeiNsCg6BDthRxEBxQ0g0BpkNDvoIQSUDCgIDXGPnE7CDmwE1yPt_IEePCQymnSU-oML0Q3gxTSPFFjjzdgh0yOwCrzdIyl6CR4NiUhj4QMSKMRR7ZPIRSedPZivV9_ulvl6dUvn1_n3-_U67SnBbH67XF5NxcvsmRY2wKvTepHdf_50t7zKb1Zfvi4vb3LJFnXMgVINimhVVYJoXdaLVrQcMGsJJ4wT3TJcKlxQLIVaFKRoBae8pRWuZEVJwS6yj0fvMLYdqMM3C9sM3nTC7xsnTPNvpzeb5ofbNQQXFaMVTYZ3J4N3P0cIselMkGCt6MGNoaE1rRkvaDmhsyMqvQvBg364h-BmSkszpaU5pSXhbx6_7QH-G48EvD0Cbhz-r_oDv9bO8A</recordid><startdate>20230830</startdate><enddate>20230830</enddate><creator>Sadahiro, Ryoichi</creator><creator>Hatta, Kotaro</creator><creator>Yamaguchi, Takuhiro</creator><creator>Masanori, Enokido</creator><creator>Matsuda, Yoshinobu</creator><creator>Ogawa, Asao</creator><creator>Iwata, Yusei</creator><creator>Tokoro, Akihiro</creator><creator>Nakahara, Rika</creator><creator>Hirayama, Takatoshi</creator><creator>Yanai, Yuko</creator><creator>Ogawa, Yuko</creator><creator>Kayano, Ayako</creator><creator>Ariyoshi, Keisuke</creator><creator>Oyamada, Shunsuke</creator><creator>Uchitomi, Yosuke</creator><creator>Akechi, Tatsuo</creator><creator>Yamamoto, Noboru</creator><creator>Okita, Natsuko</creator><creator>Yorikane, Eiko</creator><creator>Shimada, Kazuaki</creator><creator>Furukawa, Tetsuya</creator><creator>Hashimoto, Hironobu</creator><creator>Maeda, Makoto</creator><creator>Sato, Tetsufumi</creator><creator>Sekimoto, Asuko</creator><creator>Sasaki, Chiyuki</creator><creator>Saito, Eiko</creator><creator>Uezono, Yasuhito</creator><creator>Matsuoka, Hiromichi</creator><general>Oxford University Press</general><scope>TOX</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-5092-9377</orcidid><orcidid>https://orcid.org/0000-0002-7276-1971</orcidid><orcidid>https://orcid.org/0000-0002-0787-2851</orcidid><orcidid>https://orcid.org/0000-0003-1764-1763</orcidid></search><sort><creationdate>20230830</creationdate><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><author>Sadahiro, Ryoichi ; 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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.
This paper describes the protocol of a multi-centre, double-blind, randomized placebo-controlled trial evaluating the effectiveness and safety of oral ramelteon for postoperative delirium prevention in cancer patients aged ≥65 years.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>37340766</pmid><doi>10.1093/jjco/hyad061</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-5092-9377</orcidid><orcidid>https://orcid.org/0000-0002-7276-1971</orcidid><orcidid>https://orcid.org/0000-0002-0787-2851</orcidid><orcidid>https://orcid.org/0000-0003-1764-1763</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Oxford University Press Journals All Titles (1996-Current); EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Clinical Trial Note |
| 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 |
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