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Poster display

1551 - Efficacy of rikkunshito, a Japanese herbal medicine, on nausea, vomiting and anorexia in patients with uterine cervical or corpus cancer treated with cisplatin and paclitaxel –A randomized phase II study


09 Oct 2016


Poster display


Shunsuke Ohnishi


Annals of Oncology (2016) 27 (6): 497-521. 10.1093/annonc/mdw390


S. Ohnishi1, H. Watari2, M. Kanno3, Y. Oba4, S. Takeuchi5, T. Miyaji6, S. Oyamada7, E. Nomura3, H. Kato4, T. Sugiyama5, M. Asaka8, N. Sakuragi2, T. Yamaguchi9, Y. Uezono10, S. Iwase11

Author affiliations

  • 1 Department Of Gastroenterology And Hepatology, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 2 Department Of Obstetrics And Gynecology, Hokkaido University Hospital, Sapporo/JP
  • 3 Department Of Obstetrics And Gynecology, Oji General Hospital, Tokamkomai/JP
  • 4 Division Of Gynecologic Oncology, Hokkaido Cancer Center, Sapporo/JP
  • 5 Department Of Obsterics And Gynecology, Iwate Medical University School of Medicine, Morioka/JP
  • 6 Department Of Clinical Trial Data Management, The University of Tokyo Graduate School of Medicine, Tokyo/JP
  • 7 Department Of Biostatistics, Japanese Organisation for Research and Treatment of Cancer, Tokyo/JP
  • 8 Department Of Cancer Preventive Medicine, Hokkaido University Graduate School of Medicine, Sapporo/JP
  • 9 Clinical Research Data Center, Tohoku University Graduate School of Medicine, 980-8574 - Sendai/JP
  • 10 Division Of Cancer Pathophysiology, National Cancer Center Research Institute, Tokyo/JP
  • 11 Palliative Medicine, University of Tokyo-Research hospital,The Institute of Medical Science, 108-8639 - Tokyo/JP


Abstract 1551


Although antagonists for 5-HT3 and NK-1 receptors and corticosteroids are used for the treatment of chemotherapy-induced nausea and vomiting (CINV), this treatment is still insufficient. Rikkunshito (RKT), a Japanese herbal medicine, is widely prescribed in Japan to treat various gastrointestinal disorders, and has been reported to recover the decreases in food intake and serum ghrelin levels caused by cisplatin (CDDP) in animal models (Gastroenterology 2008;134:2004-13). We thus investigated whether RKT could improve CINV in patients receiving CDDP and paclitaxel (PTX).


Patients with histologically diagnosed uterine cervical or corpus cancer who were planned to receive CDDP and PTX as first-line chemotherapy were included. Patients were randomly assigned to the RKT group receiving oral administration of RKT 7.5 g/day for 14 days with standard antiemetics (granisetron, aprepitant and dexamethasone), or the control group receiving only standard antiemetics. The primary endpoint was complete control rate (CCR) in the overall phase (0-120 hours after CDDP administration), and secondary endpoints were complete response rate (CRR), total control rate, time to treatment failure, appetite and nausea assessed by VAS, FAACT anorexia and cachexia subscale scores, EORTC-QLQ-C30 scores, grade of appetite/nausea/vomiting by CTCAE v4.0, and serum level of ghrelin. Two-sided P value


Forty patients were enrolled from 4 institutions, and 36 patients (19 in the RKT group, 17 in the control group) were included in efficacy analysis. The primary endpoint CCR in the overall phase was significantly higher in the RKT group than control group (57.9% vs 35.3%, P = 0.175). Furthermore, CCR in the delayed phase (24-120 hours after CDDP administration) and CRR in overall and delayed phases were also significantly higher in the RKT group than control group (63.2% vs 35.3%, P = 0.095; 84.2% vs 52.9%, P = 0.042; 84.2% vs 52.9%, P = 0.042, respectively).


The primary endpoint CCR in the overall phase was achieved, and RKT would improve CINV, especially in the delayed phase.

Clinical trial identification


Legal entity responsible for the study

Japanese Organisation for Research and Treatment of Cancer


The Third-term Comprehensive 10-year Strategy for Cancer Control (H22-General-035) from the Ministry of Health, Labour and Welfare, Japan


All authors have declared no conflicts of interest.

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