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.

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.

Early specialized palliative care for patients with metastatic lung cancer receiving chemotherapy: a feasibility study of a nurse-led screening-triggered programme.

BACKGROUND: Strategies to implement early specialized palliative care have not yet been established. The present study investigated the feasibility of a nurse-led, screening-triggered early specialized palliative care intervention programme and obtained data to design a randomized controlled trial. METHODS: Patients with metastatic lung cancer undergoing first-line platinum-based chemotherapy were eligible. The intervention consisted of (1) a questionnaire-based screening programme and (2) advanced-level nurse counselling and care coordination with interdisciplinary team approach. The primary endpoint was the completion rate of the assessment questionnaire after the second course of first-line chemotherapy (T2). Secondary endpoints included changes in Functional Assessment of Cancer Therapy-Lung scores, depression and anxiety rates based on the Patient Health Questionnaire 9 and the Hospital Anxiety and Depression Scale, and the contents of specialized palliative care. RESULTS: A total of 50 patients were enrolled between August 2012 and March 2014. Median age was 66 years (range, 40-78 year) and 84% were male. A total of 38 patients had stage IV non-small cell lung carcinoma and 12 had extensive disease small-cell lung carcinoma. The completion rate was 70% (95% confidence interval 56.0-81.0). The median duration between baseline and T2 was 53 days. Improvement from baseline were observed at T2 in Functional Assessment of Cancer Therapy-Lung scores (86.0 ± 18.1 vs 94.9 ± 18.2, P = 0.057), depression (16.0 vs 5.7%; P = 0.26) and anxiety (32.0 vs 22.9%; P = 0.65); however, these results were not statistically significant. CONCLUSIONS: This early specialized palliative care intervention is feasible and could be useful in improving patients' quality of life. The present results justify the initiation of a randomized control trial.

JPOS/JASCC clinical guidelines for delirium in adult cancer patients: a summary of recommendation statements.

BACKGROUND: The Japanese Psycho-Oncology Society and Japanese Association of Supportive Care in Cancer recently launched the clinical practice guidelines for delirium in adult cancer patients. The aim of the guidelines was to provide evidence-based recommendations for the clinical assessment and management of delirium in cancer patients. This article reports the process of developing the guideline and summarizes the recommendations made. METHODS: The guidelines were developed in accordance with the Medical Information Network Distribution Service creation procedures. The guideline development group, consisting of multidisciplinary members, formulated nine clinical questions. A systematic literature search was conducted to identify relevant articles published prior to through 31 May 2016. Each article was reviewed by two independent reviewers. The level of evidence and the strength of the recommendations were graded using the grading system developed by the Medical Information Network Distribution Service, following the concept of The Grading of Recommendations Assessment, Development and Evaluation system. The modified Delphi method was used to validate the recommendation statements. RESULTS: This article provides a summary of the recommendations with rationales for each, as well as a short summary. CONCLUSIONS: These guidelines will support the clinical assessment and management of delirium in cancer patients. However, additional clinical studies are warranted to further improve the management of delirium.

Quality of care in hospitalized cancer patients before and after implementation of a systematic prevention program for delirium: the DELTA exploratory trial.

BACKGROUND: We evaluated whether the DELirium Team Approach (DELTA) program-a systematic management program aimed at screening high-risk groups and preventing delirium-would improve quality of care in patients hospitalized with cancer. METHODS: A retrospective before-after study was conducted during a pre-intervention period (between October 2012 and March 2013) and a post-intervention period (between October 2013 and March 2014) at a Japanese hospital providing specialized treatments for cancer. A total of 4180 inpatients were evaluated before the implementation of the DELTA program and 3797 inpatients were evaluated after implementation. RESULTS: After program implementation, the incidence of delirium decreased from 7.1 to 4.3% (odds ratio [OR], 0.52; 95% CI, 0.42-0.64). The incidence of adverse events, including falls or self-extubation, also decreased, from 3.5 to 2.6% (OR, 0.71; 95% CI, 0.54-0.92). There was a significant decrease in the prescription of benzodiazepines (OR, 0.79; 95% CI, 0.71-0.87), increase in the level of independence in activities of daily living at discharge (OR, 1.94; 95% CI, 1.11-3.38), and decrease in the length of stay (risk ratio 0.90; 95% CI, 0.90-0.90). CONCLUSIONS: The systematic management program for delirium decreased the incidence of delirium and improved several clinical outcomes. These data suggest that this simple cost-effective program is feasible and implementable as routine care in busy wards.