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

被引：1

作者：

Sadahiro, Ryoichi ^{[1
]}

Hatta, Kotaro ^{[2
]}

Yamaguchi, Takuhiro ^{[3
]}

Masanori, Enokido ^{[4
]}

Matsuda, Yoshinobu ^{[5
]}

Ogawa, Asao ^{[4
]}

Iwata, Yusei ^{[4
]}

Tokoro, Akihiro ^{[5
]}

Nakahara, Rika ^{[1
]}

Hirayama, Takatoshi ^{[1
]}

Yanai, Yuko ^{[1
]}

Ogawa, Yuko ^{[1
]}

Kayano, Ayako ^{[1
]}

Ariyoshi, Keisuke ^{[6
]}

Oyamada, Shunsuke ^{[6
]}

Uchitomi, Yosuke ^{[7
]}

Akechi, Tatsuo ^{[8
]}

Yamamoto, Noboru ^{[9
]}

Okita, Natsuko ^{[10
]}

Yorikane, Eiko ^{[10
]}

Shimada, Kazuaki ^{[11
]}

Furukawa, Tetsuya ^{[12
]}

Hashimoto, Hironobu ^{[12
]}

Maeda, Makoto ^{[12
]}

Sato, Tetsufumi ^{[13
]}

Sekimoto, Asuko ^{[14
]}

Sasaki, Chiyuki ^{[14
]}

Saito, Eiko ^{[15
]}

Uezono, Yasuhito ^{[16
]}

Matsuoka, Hiromichi ^{[1
,17
]}

机构：

[1] Natl Canc Ctr Japan, Natl Canc Ctr Hosp, Dept Psychooncol, Tokyo, Japan

[2] Juntendo Univ, Nerima Hosp, Dept Psychiat, Tokyo, Japan

[3] Tohoku Univ, Div Biostat, Grad Sch Med, Sendai, Miyagi, Japan

[4] Natl Canc Ctr Japan, Natl Canc Ctr East, Dept Psychooncol, Chiba, Japan

[5] Natl Hosp Org Kinki, Chuo Chest Med Ctr, Dept Psychosomat Internal Med, Osaka, Japan

[6] JORTC Data Ctr, NPO, Tokyo, Japan

[7] Natl Canc Ctr Japan, Inst Canc Control, Div Survivorship Res, Tokyo, Japan

[8] Nagoya City Univ, Grad Sch Med Sci, Dept Psychiat & Cognit Behav Med, Nagoya, Japan

[9] Natl Canc Ctr, Dept Expt Therapeut, Tokyo, Japan

[10] Natl Canc Ctr, Clin Trial Support Off, Tokyo, Japan

[11] Natl Canc Ctr, Natl Canc Ctr Japan, Tokyo, Japan

[12] Natl Canc Ctr Japan, Natl Canc Ctr Hosp, Dept Pharm, Tokyo, Japan

[13] Natl Canc Ctr Japan, Dept Anesthesia & Intens Care, Tokyo, Japan

[14] Natl Canc Ctr Japan, Natl Canc Ctr Hosp, Dept Nursing, Tokyo, Japan

[15] Inst Global Hlth Policy Res, Natl Ctr Global Hlth & Med, Bur Int Hlth Cooperat, Tokyo, Japan

[16] Jikei Univ, Sch Med, Dept Pain Control Res, Tokyo, Japan

[17] Natl Canc Ctr, Dept Psychooncol, 5-1-1 Tsukiji,Chuo Ku, Tokyo, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2023年 / 53卷 / 09期

关键词：

ramelteon; delirium; randomized controlled trial; cancer; JAPANESE VERSION; RATING-SCALE; VALIDATION; REVISED-98;

D O I：

10.1093/jjco/hyad061

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：851 / 857

页数：7

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