The efficacy of the Kampo medicine rikkunshito for chemotherapy-induced anorexia (RICH trial): study protocol for a randomized controlled trial

Trials

Satoshi Muto¹  Mitsuro Fukuhara¹  Yuki Matsumura¹  Hironori Takagi¹  Yuki Owada¹  Naoyuki Okabe¹  Yutaka Shio¹  Mika Hoshino¹  Yuzuru Watanabe¹  Takuya Inoue¹  Mitsunori Higuchi¹  Takumi Yamaura¹  Takeo Hasegawa¹  Jun Osugi¹  Hiroyuki Suzuki¹  Kenya Kanazawa²  Mitsuru Munakata²  Hiroshi Yokouchi²  Katsuya Ohbuchi³  Takahisa Fukushima³ 

[1] Department of Chest Surgery, Fukushima Medical University School of Medicine;Department of Respiratory Medicine, Fukushima Medical University School of Medicine;Kampo Research & Development Division, Tsumura & Co.;

关键词: Complementary medicine;    Lung cancer;    Oncology;    Medical management;    Kampo medicine;    Rikkunshito;   

DOI  :  10.1186/s13063-017-2227-6

来源: DOAJ

【 摘 要 】

Abstract Background Cisplatin 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/design This 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. Discussion 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. Trial registration Japan Pharmaceutical Information Center Clinical Trials Information (JAPIC CTI), trial registration: JAPIC CTI-142747 . Registered on 15 December 2014; the RICH trial.

【 授权许可】

Unknown