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Randomized Controlled Trial
. 2025 Jan-Dec:24:15347354251329346.
doi: 10.1177/15347354251329346. Epub 2025 Mar 29.

Efficacy of Rikkunshito on Chemotherapy-Induced Nausea and Vomiting in Patients With Uterine Corpus or Cervical Cancer Treated With Cisplatin-Based Regimen-Placebo-controlled, Double-Blind, Randomized Confirmatory Study (JORTC-KMP03)

Yosuke Konno  1 , Shunsuke Ohnishi  2 , Shinichiro Minobe  3 , Eiji Nomura  4 , Takayuki Nagasawa  5 , Etsuko Fujimoto  6 , Tatsuru Ohara  7 , Shin Nishio  8 , Hisamori Kato  9 , Yoshihito Yokoyama  10 , Etsuko Miyagi  11 , Hideki Tokunaga  12   13 , Koji Nishino  14 , Akira Kikuchi  15 , Yoshio Yoshida  16 , Takashi Iwata  17 , Daito Noguchi  18 , Wataru Kudaka  19 , Shunsuke Oyamada  20 , Keisuke Ariyoshi  20 , Kota Kihara  20 , Hidemichi Watari  1
Affiliations
Randomized Controlled Trial

Efficacy of Rikkunshito on Chemotherapy-Induced Nausea and Vomiting in Patients With Uterine Corpus or Cervical Cancer Treated With Cisplatin-Based Regimen-Placebo-controlled, Double-Blind, Randomized Confirmatory Study (JORTC-KMP03)

Yosuke Konno et al. Integr Cancer Ther. 2025 Jan-Dec.

Abstract

Background: The current standard treatment for chemotherapy-induced nausea and vomiting (CINV) with standard antiemetics is insufficient. Rikkunshito, a Japanese traditional herbal medicine, has been shown to improve cisplatin-induced anorexia and functional dyspepsia, and our exploratory study found that rikkunshito has an additive beneficial effect on CINV in patients with uterine corpus and cervical cancer receiving cisplatin containing chemotherapy (JORTC KMP-02).

Methods: One hundred eighty patients with uterine corpus or cervical cancer who were scheduled to receive treatment with a cisplatin based regimen as initial chemotherapy were enrolled across 17 Japanese institutions. Patients were randomized with a 1:1 equal allocation ratio to the rikkunshito group or placebo groups and given oral administration on days 1 to 5 with standard antiemetics (granisetron, aprepitant, and dexamethasone). The primary endpoint was complete response (CR; no vomiting or rescue medication) during the delayed phase (24-120 hours after cisplatin treatment). The secondary endpoints were complete control (CC; CR without significant nausea) and total control (TC; CR without nausea) rates during the overall (0-120 hours), acute (0-24 hours), and delayed phases, as well as the CR rate during the overall and acute phases, time to treatment failure, degree of nausea and appetite during the overall phase, and adherence to the intervention.

Results: The CR rate in the delayed phase was similar between the rikkunshito group and control groups (50.6% vs 58.9%, P = .2631), as were the secondary endpoints: CR rates in the overall and acute phases, CC and TC rates in the overall, acute, and delayed phases, degrees of nausea and appetite, and time to treatment failure.

Conclusion: Rikkunshito had no additive effect on CINV prevention in patients with uterine corpus or cervical cancer who were treated with a cisplatin based regimen and standard antiemetics.

Clinical trial registration: https://jrct.mhlw.go.jp/re/reports/detail/66957, identifier jRCT1011190007.

Keywords: Rikkunshito; cervical cancer; chemotherapy-induced nausea and vomiting; cisplatin; herbal medicine; uterine corpus cancer.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The study drug was provided by Tsumura & Co. The company plays no role in the study’s design, data collection and analysis, publication decision, or preparation of the manuscript. SOh received a speaker fee from Tsumura & Co. for 36 months before publication. The other authors state that the study was conducted without any commercial or financial relationships that could be interpreted as a potential conflict of interest.

Figures

Figure 1.
Figure 1.
CONSORT flow diagram.
Figure 2.
Figure 2.
Longitudinal variations in numerical rating scale (NRS) for nausea (A) and appetite (B).
Figure 3.
Figure 3.
Duration to treatment failure.
See this image and copyright information in PMC

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