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.
cancer
delirium
ramelteon
randomized controlled trial
Journal
Japanese journal of clinical oncology
ISSN: 1465-3621
Titre abrégé: Jpn J Clin Oncol
Pays: England
ID NLM: 0313225
Informations de publication
Date de publication:
30 Aug 2023
30 Aug 2023
Historique:
received:
30
03
2023
accepted:
25
05
2023
medline:
4
9
2023
pubmed:
21
6
2023
entrez:
21
6
2023
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 37340766
pii: 7203936
doi: 10.1093/jjco/hyad061
pmc: PMC10473272
doi:
Substances chimiques
ramelteon
901AS54I69
PON2 protein, human
EC 3.1.8.1
Aryldialkylphosphatase
EC 3.1.8.1
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
851-857Subventions
Organisme : Japan Agency for Medical Research and Development
ID : 21ck0106672h0001
Informations de copyright
© The Author(s) 2023. Published by Oxford University Press.
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