Abstract
BackgroundPreoperative anxiety and postoperative delirium affect both short- and long-term prognoses in patients with cancer; therefore, these conditions require early prevention and treatment. However, no standard preventive or therapeutic methods have been established for them. Yokukansan, a Japanese herbal medicine for the treatment of insomnia and anxiety, causes relatively few adverse drug reactions and effectively improves the behavioral and psychological symptoms of dementia. Thus, it is expected to be useful for treating and/or preventing perioperative psychiatric symptoms in patients with cancer. The objective of this study is to clarify the therapeutic effect of Yokukansan for preoperative anxiety and its preventive effect on postoperative delirium in cancer patients, as well as to confirm its safety profile.MethodsThis study is a randomized, double-blind, placebo-controlled study in cancer patients scheduled to undergo tumor resection. Patients who provide consent are randomly allocated to receive oral administration of Yokukansan or placebo, and study drug administration is continued for 4 days or longer prior to surgery. We defined two primary endpoints, change in preoperative anxiety and incidence of postoperative delirium. Secondary endpoints are severity score of postoperative delirium, duration of postoperative delirium, amount of benzodiazepines used prior to surgery, amount of antipsychotic agents used after surgery, and number of postoperative hospitalization days. We plan to complete the analysis on March 31, 2021. The target number of registered patients is 110 per group, or 220 in total.DiscussionThis study is the first randomized, double-blind, placebo-controlled study intended to clarify the effects of a Japanese herbal medicine, Yokukansan, in the prevention and treatment of perioperative psychiatric symptoms in patients with cancer. The trial was initiated on August 14, 2017, with 195 subjects randomized by October 5, 2018.Trial registrationUMIN Clinical Trials Registry (UMIN-CTR), UMIN000027561. Registered on 31 May 2017.
Highlights
Preoperative anxiety and postoperative delirium affect both short- and long-term prognoses in patients with cancer; these conditions require early prevention and treatment
In a retrospective study (n = 19) in patients who underwent colorectal surgery, we found that the incidence of postoperative delirium after Yokukansan administration was lower than in previous studies [35]
Study design The therapeutic effect of Yokukansan for preoperative anxiety, its preventive effect on postoperative delirium, and its safety in cancer patients will be confirmed in a randomized, double-blind, placebo-controlled study
Summary
Preoperative anxiety and postoperative delirium affect both short- and long-term prognoses in patients with cancer; these conditions require early prevention and treatment. It is expected to be useful for treating and/or preventing perioperative psychiatric symptoms in patients with cancer. The objective of this study is to clarify the therapeutic effect of Yokukansan for preoperative anxiety and its preventive effect on postoperative delirium in cancer patients, as well as to confirm its safety profile. Patients with cancer experience various psychiatric symptoms during the perioperative period. Patients with postoperative delirium experience increased rates of respiratory infection and complications associated with immobility and prolongation of hospitalization, and long-term adverse effects including increased mortality rate [11,12,13] and impaired cognitive function [14,15,16]. In the aforementioned observational study, postoperative delirium occurred in approximately 32% of cancer patients [5]
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