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

Overview

Journal Jpn J Clin Oncol

Publisher Oxford University Press

Specialty Oncology

Date 2023 Jun 21

PMID 37340766

Authors

Ryoichi Sadahiro

Kotaro Hatta

Takuhiro Yamaguchi

Enokido Masanori

Yoshinobu Matsuda

Asao Ogawa

Yusei Iwata

Akihiro Tokoro

Rika Nakahara

Takatoshi Hirayama

Yuko Yanai

Yuko Ogawa

Ayako Kayano

Keisuke Ariyoshi

Shunsuke Oyamada

Yosuke Uchitomi

Tatsuo Akechi

Noboru Yamamoto

Natsuko Okita

Eiko Yorikane

Kazuaki Shimada

Tetsuya Furukawa

Hironobu Hashimoto

Makoto Maeda

Tetsufumi Sato

Asuko Sekimoto

Chiyuki Sasaki

Eiko Saito

Yasuhito Uezono

Hiromichi Matsuoka

Affiliations

Soon will be listed here.

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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