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.

Transitions in palliative care: conceptual diversification and the integration of palliative care into standard oncology care.

Palliative care acknowledges the historical origin of the hospice developed in the UK during the 20th century. Palliative care initially focused primarily on end-of-life care provided at hospices, but then changed to at-home care, leading to the formation of a support system provided by the palliative care team. The palliative care team further coordinated with acute care hospitals and became involved in earlier stages of care as well, such as providing symptomatic relief in conjunction with cancer treatment. On this backdrop, the concept of palliative care itself also evolved over time. In recent years, attempts at early-stage palliative care from the initial stages of treatment are being studied with respect to cases with complications such as advanced cancer. Early-stage palliative care has been reported to improve patient quality of life (QOL), improve depression, reduce the burden on the family, and possibly improve survival prognosis for some advanced cancers. Currently, efforts to integrate palliative care into standard oncology care regimens by providing specialist palliative care and cancer treatment as a single unit are anticipated to enter more widespread practice. Such a care approach differs from conventional palliative care, which is started around the time when the end of conventional cancer treatment, and consists of applying specialist palliative care from the stage where cancer treatments are administered to address with multiple problems. Many breast cancer patients have severe problems such as esthetic outcome, sexuality and psycho-social effects associated with breast cancer itself and treatment. And it effects their QOL for a long time not only during therapy but also having done therapy or recurrence. Therefore, it may be effectiveness for patients to integrate of palliative care into standard oncology care in breast cancer, but the effect of it for only breast cancer patients has not been reported on yet. In this paper, after reviewing the concepts and historical evolution of palliative care, we describe the integration of palliative care into standard oncology care that has been making progress recently.