Abstract
BackgroundCisplatin is a key drug in lung cancer therapy. However, cisplatin is also well known to induce gastrointestinal disorders, such as chemotherapy-induced nausea and vomiting, anorexia, and weight loss. These symptoms sometimes affect patients’ quality of life and make continuation of chemotherapy difficult. Anorexia is a cause of concern for patients with cancer because a persistent loss of appetite progresses to cancer cachexia. Although evidence-based management for chemotherapy has recently been established, there is room for improvement.Methods/designThis placebo-controlled, double-blind, randomized trial will aim to determine the efficacy of the traditional Japanese Kampo medicine rikkunshito (TJ-43) for preventing anorexia caused by cisplatin-including chemotherapy in patients with lung cancer. Patients with lung cancer who plan to receive cisplatin-including chemotherapy will be recruited. Patients who provide written consent will be randomly allocated to receive either TJ-43 (arm A) or placebo (arm B) for one course of chemotherapy (21 or 28 consecutive days). Investigators and patients will be masked to the treatment assignment throughout the trial. The primary endpoint will be evaluated as the change in dietary intake from day 0 (the day before the start of chemotherapy) to day 7 of cisplatin-including chemotherapy. The two arms of the trial will comprise 30 patients each. From November 2014, a total of 60 patients will be recruited, and recruitment for the study is planned to be complete by October 2017.DiscussionThis trial is designed to examine the efficacy of rikkunshito (TJ-43) for reducing anorexia and maintaining food intake caused by cisplatin-including chemotherapy in patients with lung cancer.Trial registrationJapan Pharmaceutical Information Center Clinical Trials Information (JAPIC CTI), trial registration: JAPIC CTI-142747. Registered on 15 December 2014; the RICH trial.
Highlights
Cisplatin is a key drug in lung cancer therapy
This trial is designed to examine the efficacy of rikkunshito (TJ-43) for reducing anorexia and maintaining food intake caused by cisplatin-including chemotherapy in patients with lung cancer
We showed that the rate of late-onset chemotherapy-induced nausea and vomiting (CINV) as assessed by the Multinational Association of Supportive Care in Cancer questionnaire [16] was 76% in patients receiving TJ-43 and 40% in patients not receiving TJ-43
Summary
The aim of this trial is to examine the efficacy of TJ-43 for anorexia and food intake in patients with lung cancer who receive cisplatin-including chemotherapy. Kampo medicines, such as TJ-43, are widely used for numerous diseases in Japan. In our previous study, TJ-43 was effective for both CINV and maintaining dietary intake in patients with lung cancer who received chemotherapy. We focused on dietary intake and used meal intake as the primary endpoint In this trial, we are testing only patients with lung cancer who will receive cisplatin; based on the results; TJ-43 may be effective for chemotherapy regimens other than HEC. Abbreviations 5-HT: 5-hydroxytryptamine; ANCOVA: Analysis of covariance; CINV: Chemotherapy-induced nausea and vomiting; HEC: Highly emetogenic chemotherapy; MDIH: Mean dietary intake in hospital; QOL: Quality of life
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
