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-Reference-Cited by-同舟云学术

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

Published:2023-06-20 Issue:9 Volume:53 Page:851-857
ISSN:1465-3621
Container-title:Japanese Journal of Clinical Oncology
language:en
Short-container-title:

Author:

Sadahiro Ryoichi¹,Hatta Kotaro²,Yamaguchi Takuhiro³,Masanori Enokido⁴,Matsuda Yoshinobu⁵^ORCID,Ogawa Asao⁴,Iwata Yusei⁴,Tokoro Akihiro⁵,Nakahara Rika¹,Hirayama Takatoshi¹^ORCID,Yanai Yuko¹,Ogawa Yuko¹,Kayano Ayako¹,Ariyoshi Keisuke⁶,Oyamada Shunsuke⁶,Uchitomi Yosuke⁷,Akechi Tatsuo⁸,Yamamoto Noboru⁹^ORCID,Okita Natsuko¹⁰,Yorikane Eiko¹⁰,Shimada Kazuaki¹¹,Furukawa Tetsuya¹²,Hashimoto Hironobu¹²,Maeda Makoto¹²,Sato Tetsufumi¹³,Sekimoto Asuko¹⁴,Sasaki Chiyuki¹⁴,Saito Eiko¹⁵,Uezono Yasuhito¹⁶,Matsuoka Hiromichi¹^ORCID

Affiliation:

1. National Cancer Center Hospital, National Cancer Center Japan Department of Psycho-Oncology, , Tokyo, Japan

2. Juntendo University Nerima Hospital Department of Psychiatry, , Tokyo, Japan

3. Tohoku University Graduate School of Medicine Division of Biostatistics, , Miyagi, Japan

4. National Cancer Center East, National Cancer Center Japan Department of Psycho-Oncology, , Chiba, Japan

5. National Hospital Organization Kinki-Chuo Chest Medical Center Department of Psychosomatic Internal Medicine, , Osaka, Japan

6. NPO JORTC Data Centre, , Tokyo, Japan

7. Institute for Cancer Control, National Cancer Center Japan Division of Survivorship Research, , Tokyo, Japan

8. Nagoya City University Graduate School of Medical Sciences Department of Psychiatry and Cognitive-Behavioral Medicine, , Nagoya, Japan

9. National Cancer Center Hospital Department of Experimental Therapeutics, , Tokyo, Japan

10. National Cancer Center Hospital Clinical Trial Support Office, , Tokyo, Japan

11. National Cancer Center Japan National Cancer Center Hospital, , Tokyo, Japan

12. National Cancer Center Hospital, National Cancer Center Japan Department of Pharmacy, , Tokyo, Japan

13. National Cancer Center Japan Department of Anesthesia and Intensive Care, , Tokyo, Japan

14. National Cancer Center Hospital, National Cancer Center Japan Department of Nursing, , Tokyo, Japan

15. Bureau of International Health Cooperation, National Center for Global Health and Medicine Institute for Global Health Policy Research, , Tokyo, Japan

16. Jikei University School of Medicine Department of Pain Control Research, , Tokyo, Japan

Abstract

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.

Funder

Japan Agency for Medical Research and Development

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Radiology, Nuclear Medicine and imaging,Oncology,General Medicine

Link

https://academic.oup.com/jjco/article-pdf/53/9/851/51308815/hyad061.pdf

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