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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 (Efficacy of Rikkunshito on Chemotherapy-Induced Nausea and Vomiting)

Efficacy of Rikkunshito on Chemotherapy-Induced Nausea and Vomiting

180

The number of patients assigned to each group was 90 in both the Rokunshitou and placebo groups. The mean (standard deviation) of age (years) was 53.1 (11.7) and 54.6 (11.2), and 100% of the patients in both groups were female. The allocation adjustment factors, "age category (>/= 55 years)," "drinking habit (>/= 5 drinks per week)," and "chemotherapy (preoperative chemotherapy/postoperative adjuvant chemotherapy/chemotherapy without surgery planned)" were 54.4% and 53.3%/45.6% and 46.7% in the Rokunshitou group and placebo group, respectively. There was no significant imbalance between the groups: 16.7%/16.7%/83.3%/83.3% and 12.2%/14.4%/76.7%/77.8%/11.1%/7.8%, respectively.

The first case was enrolled in this study on January 23, 2020, and the target number of 180 cases was reached on April 15, 2022, completing case enrollment. Two of the cases were discontinued, one due to an allergy to paclitaxel and the other due to a desire for standard therapy.The number of patients who completed the prescribed protocol treatment was 88 and 90 in each group, respectively, and the number of patients in both the efficacy and safety analysis groups (=treated cases) was 89 and 90 in each group.

There were five Grade 4 adverse events that occurred during the protocol treatment period that were causally related to the protocol treatment. One case of nausea occurred in the placebo group, one case of vomiting occurred in the placebo group, one case of anorexia occurred in both the Rikkunshitou and placebo groups, and one case of general fatigue occurred in the placebo group.

Primary endpoints: The point estimates (95% confidence interval) of the percentage of complete inhibition of emesis in the delayed emesis period in the Rikkunshitou and placebo groups were 50.56 (40.17, 60.95) and 58.89 (48.72, 69.05), respectively. The p-value of the chi-square test for the null hypothesis that the percentage of complete suppression of emesis in the delayed emesis period is equal in the Rikkunshitou group and the placebo group, conducted as the main analysis, was 0.2631, indicating no statistically significant difference between the groups at the two-sided significance level of 5%. Secondary endpoints: The point estimates for the rate of complete suppression of emesis in the acute phase and the overall period, and the rate of complete control of emesis and total control of emesis in the acute phase, delayed phase, and overall period were slightly lower with the Rikkunshitou group in the delayed phase and the overall period. Only the rates of complete control of emesis and total control of nausea and vomiting in the acute phase were higher with the Rikkunshitou group, but the difference from the placebo group was small.

Overall, the superiority of the Rikkunshitou group over the placebo group was not verified.

Dec. 31, 2023

Dec. 31, 2023

No

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https://jrct.niph.go.jp/latest-detail/jRCT1011190007

Watari Hidemichi

Hokkaido University Hospital

Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido

watarih@med.hokudai.ac.jp

Konno Yosuke

Hokkaido University Hospital

Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido

+81-11-706-5941

konsuke1@med.hokudai.ac.jp

Complete

Dec. 02, 2019

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1) Patients with histologically diagnosed uterine cervical or corpus cancer
2) Patients who voluntarily sign the Certified Review Board-approved written informed consent
3) Patients who noticed as cervical or corpus cancer by their doctor
4) Patients who expected to live more than 3months
5) Patients aged >= 20 years at time of enrolment.
6) Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0-2
7) Patients planned to receive chemotherapy including >= 50 mg/m2 of cisplatin as first-line chemotheray
8) Patients who can take drugs and food orally
9) Patients with the following laboratory tests:
1. White blood cell count >= 3000/microL and <= 12000/microL.
2. Neutrophil count >= 1500/microL.
3. Platelet count >= 100,000/microL.
4. Hemoglobin >= 8.0 g/dL.
5. Aspartate aminotransferase <= 100 IU/L.
6. Alanine aminotransferase <= 100 IU/L.
7. Total bilirubin <= 2.0 mg/dL.
8. Potassium >= 3.0 mEq/L
9. Creatinine clearance >= 60 mL/min.
10. No abnormality in electrocardiography (ECG).

1) Patients with brain metastasis .
2) Patients with double cancer.
3) Patients with treatment-required seizure.
4) Patients with unconsciousness.
5) Patients with gastrointestinal obstruction.
6) Patients with peritoneal dissemination.
7) Patients with vomiting, or nausea greater than grade 2 as described by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
8) Patients who are registered to a clinical trial using another medicine.
9) Patients with uncontrollable hypertension.
10) Patients with uncontrollable diabetes mellitus or treated with insulin.
11) Patients treated with corticosteroids, androgen, progestin, traditional Chinese medicine and other drugs with an appetite enhancing effect within one month
12) Patients treated with opioids.
13) Pregnant or breast-feeding women, or those who cannot use contraceptives.
14) Patients with any uncontrollable infectious disease.
15) Patients with body temperature >= 38 degrees.
16) Patients with psychosis.
17) Patients who are alcoholic.
18) Patients who are planned to receive radiotherapy.

Female

uterine cervical or corpus cancer

Patients will be randomly assigned to the rikkunshito group or the placebo group. All patients will receive chemotherapy with intravenous (IV) cisplatin >= 50 mg/m2.

Antiemetics; Nausea; Vomiting; Rikkunshito

Placebo-Controlled, Double-Blind, Randomized Confirmatory Study

CR(no vomiting and no rescue therapy) rate during the delayed phase(24-120 h after cisplatin treatment).

1) CC(CR with no more than mild nausea (NRS<= 3)) rate during the delayed phase
2) TC(CR with no nausea) rate during the delayed phase
3) CR,CC,TC rate during the overall phase (0-120 h after cisplatin treatment)
4) CR,CC,TC rate during the acute phase (0-24 h after cisplatin treatment)
5) Time to treatment failure (i.e., time to the first emetic episode or time to rescue medication) during the overall phase
6) NRS of nausea and appetite during the overall phase
7) Adherence to intervention

+81-11-706-7934

Aug. 13, 2019

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