Evidence map›Paper›PMID 37340766›Full record

ArticleJapanese journal of clinical oncology2023

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.

Ryoichi Sadahiro, Kotaro Hatta, Takuhiro Yamaguchi, Enokido Masanori, Yoshinobu Matsuda, Asao Ogawa, Yusei Iwata, Akihiro Tokoro, Rika Nakahara, Takatoshi Hirayama and 20 more

Open access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Japanese journal of clinical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.4field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors at 8 institutions in 1 country.

Ryoichi SadahiroDepartment of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Kotaro HattaDepartment of Psychiatry, Juntendo University Nerima Hospital, Tokyo, Japan.
Takuhiro YamaguchiDivision of Biostatistics, Tohoku University Graduate School of Medicine, Miyagi, Japan.
Enokido MasanoriDepartment of Psycho-Oncology, National Cancer Center East, National Cancer Center Japan, Chiba, Japan.
Yoshinobu MatsudaDepartment of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.ORCID 0000-0001-5092-9377
Asao OgawaDepartment of Psycho-Oncology, National Cancer Center East, National Cancer Center Japan, Chiba, Japan.
Yusei IwataDepartment of Psycho-Oncology, National Cancer Center East, National Cancer Center Japan, Chiba, Japan.
Akihiro TokoroDepartment of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.
Rika NakaharaDepartment of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Takatoshi HirayamaDepartment of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.ORCID 0000-0003-1764-1763
Yuko YanaiDepartment of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Yuko OgawaDepartment of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Ayako KayanoDepartment of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Keisuke AriyoshiJORTC Data Centre, NPO, Tokyo, Japan.
Shunsuke OyamadaJORTC Data Centre, NPO, Tokyo, Japan.
Yosuke UchitomiDivision of Survivorship Research, Institute for Cancer Control, National Cancer Center Japan, Tokyo, Japan.
Tatsuo AkechiDepartment of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Noboru YamamotoDepartment of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-0787-2851
Natsuko OkitaClinical Trial Support Office, National Cancer Center Hospital, Tokyo, Japan.
Eiko YorikaneClinical Trial Support Office, National Cancer Center Hospital, Tokyo, Japan.
Kazuaki ShimadaNational Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Tetsuya FurukawaDepartment of Pharmacy, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Hironobu HashimotoDepartment of Pharmacy, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Makoto MaedaDepartment of Pharmacy, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Tetsufumi SatoDepartment of Anesthesia and Intensive Care, National Cancer Center Japan, Tokyo, Japan.
Asuko SekimotoDepartment of Nursing, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Chiyuki SasakiDepartment of Nursing, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Eiko SaitoInstitute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo, Japan.
Yasuhito UezonoDepartment of Pain Control Research, Jikei University School of Medicine, Tokyo, Japan.
Hiromichi MatsuokaDepartment of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.ORCID 0000-0002-7276-1971
National Cancer Center Hospital East · JPNHO Kinki Chuo Chest Medical Center · JPJikei University School of Medicine · JPJuntendo University Nerima Hospital · JPNagoya City University · JPNational Center for Global Health and Medicine · JPTohoku University · JPTokyo National Hospital · JP

Funding

Japan Agency for Medical Research and Development 21ck0106672h0001
6 · The paper itself

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.

Indexed as

DeliriumEmergence DeliriumNeoplasmsAgedAryldialkylphosphataseClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDouble-Blind MethodHumansIndenesMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicAryldialkylphosphataseIndenesPON2 protein, humanramelteoncancerdeliriumramelteonrandomized controlled trial

Identifiers

PMID37340766
PMCPMC10473272
OpenAlexW4381469891

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.