Additive effect of rikkunshito, an herbal medicine, on chemotherapy-induced nausea, vomiting, and anorexia in uterine cervical or corpus cancer patients treated with cisplatin and paclitaxel: results of a randomized phase II study (JORTC KMP-02)

Ohnishi, Shunsuke; Watari, Hidemichi; Kanno, Maki; Ohba, Yoko; Takeuchi, Satoshi; Miyaji, Tempei; Oyamada, Shunsuke; Nomura, Eiji; Kato, Hidenori; Sugiyama, Toru; Asaka, Masahiro; Sakuragi, Noriaki; Yamaguchi, Takuhiro; Uezono, Yasuhito; Iwase, Satoru

J Gynecol Oncol. 2017 Sep;28(5):e44. 10.3802/jgo.2017.28.e44.

Additive effect of rikkunshito, an herbal medicine, on chemotherapy-induced nausea, vomiting, and anorexia in uterine cervical or corpus cancer patients treated with cisplatin and paclitaxel: results of a randomized phase II study (JORTC KMP-02)

Affiliations

¹Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
²Department of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
³Department of Obstetrics and Gynecology, Oji General Hospital, Tomakomai, Japan.
⁴Division of Gynecologic Oncology, National Hospital Organization, Hokkaido Cancer Center, Sapporo, Japan.
⁵Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Japan.
⁶Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
⁷Department of Biostatistics, Japanese Organisation for Research and Treatment of Cancer, Tokyo, Japan.
⁸Cancer Preventive Institute, Health Sciences University of Hokkaido, Tobetsu, Japan.
⁹Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.
¹⁰Division of Cancer Pathophysiology, Group for Translational Research, National Cancer Center Research Institute, Tokyo, Japan. yuezono@ncc.go.jp
¹¹Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.

KMID: 2413215
DOI: http://doi.org/10.3802/jgo.2017.28.e44

Abstract

OBJECTIVE
Rikkunshito, an herbal medicine, is widely prescribed in Japan for the treatment of anorexia and functional dyspepsia, and has been reported to recover reductions in food intake caused by cisplatin. We investigated whether rikkunshito could improve chemotherapy-induced nausea and vomiting (CINV) and anorexia in patients treated with cisplatin.
METHODS
Patients with uterine cervical or corpus cancer who were to receive cisplatin (50 mg/m² day 1) and paclitaxel (135 mg/m² day 0) as first-line chemotherapy were randomly assigned to the rikkunshito group receiving oral administration on days 0-13 with standard antiemetics, or the control group receiving antiemetics only. The primary endpoint was the rate of complete control (CC: no emesis, no rescue medication, and no significant nausea) in the overall phase (0-120 hours). Two-tailed p<0.20 was considered significant in the planned analysis.
RESULTS
The CC rate in the overall phase was significantly higher in the rikkunshito group than in the control group (57.9% vs. 35.3%, p=0.175), as were the secondary endpoints: the CC rate in the delayed phase (24-120 hours), and the complete response (CR) rates (no emesis and no rescue medication) in the overall and delayed phases (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), and time to treatment failure (p=0.059). Appetite assessed by visual analogue scale (VAS) appeared to be superior in the rikkunshito group from day 2 through day 6.
CONCLUSION
Rikkunshito provided additive effect for the prevention of CINV and anorexia.

Keyword

Anorexia; Antiemetics; Nausea; Vomiting; Rikkunshito

MeSH Terms

Adult
Aged
Anorexia/chemically induced/prevention & control
Antiemetics/administration & dosage
Antineoplastic Agents/*adverse effects/therapeutic use
Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
Cisplatin/administration & dosage/*adverse effects
Drugs, Chinese Herbal/*therapeutic use
Female
Humans
Japan
Middle Aged
Nausea/chemically induced/prevention & control
Paclitaxel/administration & dosage/*adverse effects
Uterine Cervical Neoplasms/*drug therapy
Uterine Neoplasms/*drug therapy
Vomiting/chemically induced/prevention & control
Antiemetics
Antineoplastic Agents
Drugs, Chinese Herbal
Paclitaxel
Cisplatin

Additive effect of rikkunshito, an herbal medicine, on chemotherapy-induced nausea, vomiting, and anorexia in uterine cervical or corpus cancer patients treated with cisplatin and paclitaxel: results of a randomized phase II study (JORTC KMP-02)

Abstract

Keyword

MeSH Terms

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