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).

IF 2.9 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Cancer Therapies Pub Date : 2025-01-01 Epub Date: 2025-03-29 DOI:10.1177/15347354251329346

Yosuke Konno, Shunsuke Ohnishi, Shinichiro Minobe, Eiji Nomura, Takayuki Nagasawa, Etsuko Fujimoto, Tatsuru Ohara, Shin Nishio, Hisamori Kato, Yoshihito Yokoyama, Etsuko Miyagi, Hideki Tokunaga, Koji Nishino, Akira Kikuchi, Yoshio Yoshida, Takashi Iwata, Daito Noguchi, Wataru Kudaka, Shunsuke Oyamada, Keisuke Ariyoshi, Kota Kihara, Hidemichi Watari

{"title":"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).","authors":"Yosuke Konno, Shunsuke Ohnishi, Shinichiro Minobe, Eiji Nomura, Takayuki Nagasawa, Etsuko Fujimoto, Tatsuru Ohara, Shin Nishio, Hisamori Kato, Yoshihito Yokoyama, Etsuko Miyagi, Hideki Tokunaga, Koji Nishino, Akira Kikuchi, Yoshio Yoshida, Takashi Iwata, Daito Noguchi, Wataru Kudaka, Shunsuke Oyamada, Keisuke Ariyoshi, Kota Kihara, Hidemichi Watari","doi":"10.1177/15347354251329346","DOIUrl":null,"url":null,"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.","PeriodicalId":13734,"journal":{"name":"Integrative Cancer Therapies","volume":"24 ","pages":"15347354251329346"},"PeriodicalIF":2.9000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954530/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Integrative Cancer Therapies","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/15347354251329346","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/29 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}

引用次数: 0

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.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

Integrative Cancer Therapies 医学-全科医学与补充医学

CiteScore

4.80

自引率

3.40%

发文量

审稿时长

>12 weeks

期刊介绍： ICT is the first journal to spearhead and focus on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments. Contributors are leading oncologists, researchers, nurses, and health-care professionals.