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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.
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.
Afiliação
  • Sadahiro R; Department of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Hatta K; Department of Psychiatry, Juntendo University Nerima Hospital, Tokyo, Japan.
  • Yamaguchi T; Division of Biostatistics, Tohoku University Graduate School of Medicine, Miyagi, Japan.
  • Masanori E; Department of Psycho-Oncology, National Cancer Center East, National Cancer Center Japan, Chiba, Japan.
  • Matsuda Y; Department of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.
  • Ogawa A; Department of Psycho-Oncology, National Cancer Center East, National Cancer Center Japan, Chiba, Japan.
  • Iwata Y; Department of Psycho-Oncology, National Cancer Center East, National Cancer Center Japan, Chiba, Japan.
  • Tokoro A; Department of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.
  • Nakahara R; Department of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Hirayama T; Department of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Yanai Y; Department of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Ogawa Y; Department of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Kayano A; Department of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Ariyoshi K; JORTC Data Centre, NPO, Tokyo, Japan.
  • Oyamada S; JORTC Data Centre, NPO, Tokyo, Japan.
  • Uchitomi Y; Division of Survivorship Research, Institute for Cancer Control, National Cancer Center Japan, Tokyo, Japan.
  • Akechi T; Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
  • Yamamoto N; Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.
  • Okita N; Clinical Trial Support Office, National Cancer Center Hospital, Tokyo, Japan.
  • Yorikane E; Clinical Trial Support Office, National Cancer Center Hospital, Tokyo, Japan.
  • Shimada K; National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Furukawa T; Department of Pharmacy, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Hashimoto H; Department of Pharmacy, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Maeda M; Department of Pharmacy, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Sato T; Department of Anesthesia and Intensive Care, National Cancer Center Japan, Tokyo, Japan.
  • Sekimoto A; Department of Nursing, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Sasaki C; Department of Nursing, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
  • Saito E; Institute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo, Japan.
  • Uezono Y; Department of Pain Control Research, Jikei University School of Medicine, Tokyo, Japan.
  • Matsuoka H; Department of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Jpn J Clin Oncol ; 53(9): 851-857, 2023 Aug 30.
Article em En | MEDLINE | ID: mdl-37340766
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Delírio / Delírio do Despertar / Neoplasias Tipo de estudo: Clinical_trials / Etiology_studies / Guideline / Observational_studies Limite: Aged / Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Delírio / Delírio do Despertar / Neoplasias Tipo de estudo: Clinical_trials / Etiology_studies / Guideline / Observational_studies Limite: Aged / Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article