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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Takuya Inoue, Hironori Takagi, Yuki Owada, Yuzuru Watanabe, Takumi Yamaura, Mitsuro Fukuhara, Satoshi Muto, Naoyuki Okabe, Yuki Matsumura, Takeo Hasegawa, Jun Osugi, Mika Hoshino, Mitsunori Higuchi, Yutaka Shio, Hiroshi Yokouchi, Kenya Kanazawa, Katsuya Ohbuchi, Takahisa Fukushima, Mitsuru Munakata, Hiroyuki Suzuki

Published in: Trials | Issue 1/2017

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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.
Appendix
Available only for authorised users
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Metadata
Title
The efficacy of the Kampo medicine rikkunshito for chemotherapy-induced anorexia (RICH trial): study protocol for a randomized controlled trial
Authors
Takuya Inoue
Hironori Takagi
Yuki Owada
Yuzuru Watanabe
Takumi Yamaura
Mitsuro Fukuhara
Satoshi Muto
Naoyuki Okabe
Yuki Matsumura
Takeo Hasegawa
Jun Osugi
Mika Hoshino
Mitsunori Higuchi
Yutaka Shio
Hiroshi Yokouchi
Kenya Kanazawa
Katsuya Ohbuchi
Takahisa Fukushima
Mitsuru Munakata
Hiroyuki Suzuki
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2227-6

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